Allan B. Massie, PhD, is an associate professor in the Department of Surgery and an associate professor in the Department of Population Health at NYU Langone.

Conor Donnelly, MD, is a surgical resident at NYU Langone.

Michal A. Mankowski, PhD, is a research assistant professor at the Department of Surgery at NYU Langone.

Don’t Forget to Follow Up: Kidney Transplant Referral Is Only the Beginning

Nearly half of patients referred for kidney transplantation never begin the evaluation process required to be considered for a new organ, according to a new study from NYU Langone Health, highlighting the need for continued follow-up and support after referral.

In the largest and most detailed study to date, using Epic Cosmos, a dataset of more than 300 million electronic health records from over 1,850 hospitals, examining attrition throughout the kidney transplant pathway, investigators found that social vulnerability, severe obesity, patient characteristics, and transplant center factors may influence whether patients progress from referral to evaluation, waitlisting, and transplantation.

Can Transplant Center Referral Impact Kidney Transplant Evaluation?

Why Fewer Than Half of Referred Patients Reach Kidney Transplant Evaluatio

Using data from 720,348 adults referred for kidney transplantation, researchers found that 48% of patients never initiated an evaluation, while only 19% completed the evaluation process and reached the waitlist.

“We really learned from this study that every stage matters. Nephrologists have to follow through, not just make a referral,” Allan B. Massie, PhD, associate professor in the Departments of Surgery and Population Health at NYU Grossman School of Medicine, told HCPLive.

Factors Associated With Lower Progression Through the Transplant Pathway

The study identified several factors associated with a reduced likelihood of advancing through the transplant pathway, including being unmarried, having severe obesity, living in rural areas, or experiencing greater socioeconomic vulnerability.

Investigators also found differences based on transplant center characteristics, with patients treated at smaller centers or programs in certain regions less likely to advance through the process.

Severe obesity was one factor associated with lower progression through the transplant pathway. Investigators emphasized that the findings were specific to severe obesity rather than obesity more broadly.

“It’s important to recognize severe obesity as a factor. We are seeing a 70% decrease in the rate of transplantation among patients with severe obesity, so it’s just a population to identify and be aware of for nephrologists, especially,” said Conor Donnelly, MD, resident and PhD student in the Department of Surgery at NYU Grossman School of Medicine.

Although some patients may appropriately be excluded from transplantation because of medical concerns, investigators emphasized that many patients may fail to progress for reasons unrelated to medical eligibility.

“It’ll never be the case that every patient referred for transplantation is going to be listed and transplanted. There are some patients who are genuinely ineligible for medical reasons,” Massie said. “However, at the same time, our study leads us to believe that many patients are failing to progress for reasons other than medical criteria.”

What Can Clinicians and Transplant Centers Do Differently?

Investigators emphasized that improving access to transplantation will require support throughout the entire process, beginning soon after referral.

“Transplant centers have to lower barriers to getting appointments, establishing a relationship with the transplant team to identify patient-specific barriers and help them overcome them,” Massie said. “It really depends on a team coming together to provide holistic care for the patient.”

Support may include helping patients navigate appointments, transportation challenges, and other logistical barriers that emerge early in the evaluation process.

“When you’re looking at support, whether it’s helping patients with transportation or helping them with costs associated with the whole process, it’s important to understand that these costs are incurred early on,” Donnelly said. “Supporting them involves identifying these patients that could benefit from it, and then supporting them at these earlier stages.”

Mankowski also emphasized the importance of education and communication as patients enter a complex and unfamiliar process.

“Education and support are important because the process is very complex, and often patients are in touch with a completely new team. They have to do a lot of different testing, probably now in different places, and interact with teams that they never interacted with before,” said Michal A. Mankowski, PhD, assistant professor in the Department of Surgery at NYU Grossman School of Medicine. “Staying in touch and helping navigate, at least early on, will be a great win.”

The investigators noted that future interventions will likely need to be tailored to individual populations, as barriers may differ across geographic regions and patient communities. However, they emphasized that identifying where patients are lost in the transplant pathway is an important first step toward improving access.

“Tracking is critical to understanding how this process evolves over time. Our study shows that this is not getting better, and continuing to monitor these trends will help us build a better system, which is what we all want to do,” Donnelly said.

Editor's Note: Donnelly, Mankowski, and Massie report no relevant disclosures.

Donnelly, C. B., Patel, S. S., Husain, S. A., Gentry, S. E., Patzer, R. E., Lonze, B. E., Bae, S., Axelrod, D., Orandi, B. J., McAdams-DeMarco, M. A., Segev, D. L., Massie, A. B., & Mankowski, M. A. (2026). 

Evaluating Barriers to Kidney Transplantation in the United States.

 Journal of the American Society of Nephrology. 

Most People Seeking a Kidney Transplant Never Reach the Waitlist. NYU Langone News. Published 2026. Accessed July 15, 2026. https://nyulangone.org/news/most-people-seeking-kidney-transplant-never-reach-waitlist

Videos

NYU Langone’s Conor Donnelly, Allan Massie, and Michal Mankowski explain why follow-up after kidney transplant referral is critical to improving access.

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Chronic Kidney Disease

Strategic Alliance Partnership

Don’t Forget to Follow Up After Kidney Transplant Referral

Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Nihar Desai, MD
Credit: Yale School of Medicine

The triglyceride treatment landscape is shifting quickly, and nowhere is that more apparent than in the management of severe hypertriglyceridemia. 

As new therapies enter practice, clinicians across specialties are being asked to sharpen their index of suspicion for rare, genetic forms of the disease that conventional 

That evolving picture framed a clinical forum held May 6, 2026, in Boston, Massachusetts, where Nihar Desai, MD, MPH, of Yale School of Medicine, led cardiologists, endocrinologists, a nephrologist, and primary care physicians through a discussion of 

, an autosomal recessive disorder driven by loss of lipoprotein lipase (LPL) activity.

FCS results from complete or partial LPL deficiency, most often due to biallelic loss-of-function variants in the LPL gene, allowing chylomicrons and very low-density lipoprotein to accumulate in the bloodstream.¹ 

The condition is rare, affecting an estimated 1 to 19 per million people, and typically presents in childhood with fasting triglycerides persistently at or above 880 mg/dL. That distinguishes it from multifactorial chylomicronemia syndrome, a more common, largely polygenic condition presenting in adulthood that responds at least modestly to statins, fibrates, or omega-3 therapy, unlike FCS.¹

Participants described the diagnostic odyssey many patients with FCS experience before a clinician connects the dots. One described a patient diagnosed with severe hypertriglyceridemia at age 7 whose levels ran between 4000 and 6000 mg/dL by age 24, despite trials of conventional agents. Desai noted that patients are seen by an average of five providers before a correct diagnosis is made, nearly half are initially misdiagnosed, and about three in four are diagnosed within the first decade of life.

The clinical stakes of delayed recognition are significant. Patients with FCS face an estimated 60% to 90% lifetime risk of acute pancreatitis, with recurrent episodes in more than half of patients and mortality reaching 5% to 6%.² Desai cited survey data showing two-thirds of patients report the condition significantly affects self-worth, emotional well-being, sleep, and mental functioning. 

Participants discussed formal scoring systems, including the North American FCS calculator and the European diagnostic scoring system, as tools to formalize clinical suspicion, though several noted family history can be an unreliable prompt given the autosomal recessive inheritance pattern, which often produces sporadic-appearing cases.

Participants converged on triglyceride thresholds as practical referral triggers. Several described referring patients above 500 mg/dL to a lipid specialist, while one nephrologist reserved referral for suspected genetic cases even below that threshold. Barriers to genetic testing were recurring, including cost, appointment burden, and inconsistent insurance coverage, though at least one commercial testing program offers no-cost sequencing for patients with sufficient clinical suspicion.

Desai reviewed current standard-of-care lifestyle measures, including a very-low-fat diet of 10% to 15% of calories, fat-soluble vitamin supplementation, alcohol abstinence, and selective use of medium-chain triglyceride oil, which does not form chylomicrons. Several participants said these measures are difficult to sustain long-term, citing limited access to purified medium-chain triglyceride oil products and the pervasiveness of dietary fat in daily life.

The forum's central focus was the pharmacologic landscape targeting apolipoprotein C-III (APOC3), a key inhibitor of LPL activity and of LPL-independent chylomicron clearance. 

Two APOC3-directed therapies are now FDA-approved: 

olezarsen, an antisense oligonucleotide dosed every 4 weeks and approved in December 2024

plozasiran, a small interfering RNA dosed every 3 months and approved in November 2025.

Both agents degrade APOC3 messenger RNA before the protein is produced, restoring chylomicron clearance through LPL-dependent and LPL-independent pathways, Desai explained.³

In the phase 3 BALANCE trial, olezarsen 80 mg reduced triglycerides by approximately 40% to 45% at steady state versus placebo, with serious adverse events in 14% of the 80-mg group compared with 39% of placebo.³ 

In the phase 3 PALISADE trial, plozasiran produced roughly 70% reductions in triglycerides and 90% suppression of APOC3 by months 10 and 12, with an 83% relative reduction in acute pancreatitis risk versus placebo.⁴ 

Desai noted the olezarsen trial enrolled only genetically confirmed FCS, while the plozasiran trial allowed a broader population including clinically diagnosed, symptomatic persistent chylomicronemia, a distinction participants said could influence therapy selection absent confirmed biallelic variants.

Several participants described relying on dedicated pharmacy teams to navigate prior authorization and patient assistance programs, without which access remained a persistent obstacle. One participant said cost and coverage, more than clinical uncertainty, remain the primary barriers to broader adoption, while another wanted longer-term, real-world phase 4 tolerability data before feeling fully comfortable prescribing.

Participants closed by reflecting on how far management options have advanced, and on the importance of building referral pathways before a patient's first pancreatitis episode rather than after. Desai emphasized that with two approved therapies now available, the task facing clinicians outside lipid subspecialty practice is recognizing the syndrome early enough to act, since diagnosis alone can now change these patients' clinical trajectory.

Brinton EA, Hegele RA, Gaudet D, et al. Familial chylomicronemia syndrome. Atherosclerosis. 2025;403:119114.

Sanchez RJ, Ge W, Wei W, Ponda D, Rajpathak S. The association of triglyceride levels with the incidence of initial and recurrent acute pancreatitis. Lipids Health Dis. 2021;20:72.

Stroes ESG, Alexander VJ, Karwatowska-Prokopczuk E, et al. Olezarsen, acute pancreatitis, and familial chylomicronemia syndrome. N Engl J Med. 2024;390(19):1781-1792.

Watts GF, Gidding SS, Mata P, et al. Plozasiran for managing persistent chylomicronemia and familial chylomicronemia syndrome. N Engl J Med. 2025;392(2):127-137.

Articles

Familial chylomicronemia syndrome (FCS) is a rare autosomal recessive disorder of absent or reduced lipoprotein lipase activity, causing lifelong, extreme hypertriglyceridemia and high pancreatitis risk. It is frequently misdiagnosed as multifactorial chylomicronemia, delaying effective intervention despite hallmark fasting triglycerides ≥880 mg/dL, often from childhood. Sustained dietary fat restriction remains foundational but difficult. Two FDA-approved APOC3-silencing therapies—olezarsen and plozasiran—now enable substantial triglyceride lowering and may reduce pancreatitis, making early recognition and referral critical.

A multidisciplinary clinical forum discussed diagnosis, referral thresholds, and the evolving APOC3-targeted treatment landscape for FCS.

Cardiology

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Dyslipidemia

Diagnosing and Treating Familial Chylomicronemia Syndrome: Perspectives from a Clinical Forum

Dr. Martin is an assistant professor at the Ciccarone Center for the Prevention of Heart Disease at the Johns Hopkins University School of Medicine.

New Martin-Hopkins LDL-C-Estimating Equation Simplifies Implementation for Comparable Results

A new investigation into the Martin-Hopkins equation has produced a simplified version of the 

 calculation to streamline care and broaden implementation.

The original Martin-Hopkins Equation was developed in response to the rising importance of LDL-C calculation and the continuous risk of underestimating LDL-C levels. However, the equation, first drafted in 2013, requires some laboratories to undertake extra steps in implementing it for patients. To this end, investigators at Johns Hopkins University aimed to streamline the system into something universally applicable and accessible.

“The equation itself is a bit complex, but it can be coded into the lab IT system as a single line of code, so clinicians never need to deal with that complexity,” Seth Martin, MD, MHS, a professor in the division of cardiology at Johns Hopkins University and an investigator in the study, told 

 in an exclusive interview. “It makes it easier for lab directors to implement this, because they can take the line of code that currently is offered with the Friedewald equation to calculate LDL cholesterol, replace it with this new line of code, and get substantially enhanced LDL cholesterol accuracy.”

Martin and colleagues included patients from the second harvest of the Very Large Database of Lipids (VLDBL), which was collected from several US clinics from October 2015 to June 2019. These patients exhibit similar lipid distributions to those of the broader US population. Patients with missing values for total cholesterol, HDL-C, triglycerides, or LDL-C concentration were excluded. The primary analysis focused on patients with triglyceride concentrations <400 mg/dL.

The team measured patients’ total cholesterol, LDL-C, VLDL-C, and HDL-C concentrations using the Vertical Auto Profile (VAP) test. Triglyceride measurements utilized the Abbott ARCHITECT C-8000 system. Additionally, the team implemented the Friedewald equation, the Martin-Hopkins equation, the extended Martin-Hopkins equation, the Sampson-National Institutes of Health equation, and the modified Sampson-National Institutes of Health equation.

Machine-learning methods were also employed – Martin and colleagues estimated VLDL-C using total cholesterol, triglyceride, and HDL-C concentrations as independent variables, followed by calculating LDL-C concentration by subtracting VLDL-C from non-HDL-C. Of the 3 machine learning algorithms implemented in the study, MARS created a new equation for the estimation of VLDL-C.

Martin and colleagues then conducted a statistical analysis of the new equation, randomly assigning patients in a 2:1 ratio to either a training or test dataset. Of the initial 5,081,680 patients in the dataset, 10,856 were excluded for incomplete data, and 131,296 were removed for having triglyceride concentrations ≥400 mg/dL. Of the remaining patients, 3,292,889 were assigned to the training dataset and 1,646,639 to the test dataset. Median LDL-C concentration was 114 mg/dL (interquartile ratio [IQR], 90-141), and the median triglyceride/VLDL-C ratio was 5.1 (IQR, 4.4 to 5.9) for both groups.

During the test, the MARS equation showed minimal bias in estimating LDL-C concentration (median [IQR], -0.1; -2.1 to 1.8 mg/dL), comparable with the existing Martin-Hopkins equation. The median difference between the 2 was -0.5 (-1.2 to 0) mg/dL, indicating the methods’ potential comparability. Additionally, the proportion of patients correctly classified to each clinical category was almost identical for the MARS equation and the Martin-Hopkins equation, with 89.7% and 89.6% of patients correctly assigned, respectively.

Ultimately, the team determined that this newer version of the Martin-Hopkins equation, developed by the MARS machine learning algorithm, may provide the same quality of results while simplifying its implementation.

“We have extensive external validation with the original equation – this one performs similarly, and we have additional external validation included in this paper,” Martin said. “I think this is an equation that’s ready for implementation and really has robust science behind it.”

Editors’ Note: Martin reports disclosures with Amgen, Merck, Arrowhead, Verve Therapeutics, Novartis, Regeneron, and others.

Park J, Fan L, Marzinke MA, et al. Development and validation of a simplified Martin-Hopkins LDL-C equation using machine learning. JAMA Cardiology. Published online July 15, 2026. 

Johns Hopkins Medicine. Machine Learning Method Enables Easier and Wider Use of Martin-Hopkins Equation to Accurately Assess LDL Cholesterol Risk. July 15, 2026. Accessed July 16, 2026. 

https://www.hopkinsmedicine.org/news/newsroom/news-releases/2026/07/machine-learning-method-enables-easier-and-wider-use-of-martin-hopkins-equation-to-accurately-assess-ldl-cholesterol-risk

Seth Martin, MD, MHS, discusses his recent study, which produced an AI-optimized equation that only requires 1 line of code.

Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

Treprostinil palmitil inhalation powder (TPIP; Insmed), an investigational once-daily dry powder prostanoid prodrug, demonstrated sustained improvements across all secondary efficacy endpoints at 12 months in an ongoing open-label extension (OLE) study in patients with 

 (PAH), Insmed announced July 16, 2026.¹ Patients who had received placebo in the lead-in Phase 2b trial and crossed over to TPIP in the OLE achieved outcomes comparable to those who had received TPIP continuously, suggesting a treatment response after delayed initiation.

The findings support advancement of the Phase 3 PALM-PAH trial, a randomized, double-blind, placebo-controlled study now enrolling patients with PAH, with change in 6-minute walk distance (6MWD) as its primary endpoint.¹

OLE Results Support PALM-PAH Phase 3 Trial

The 24-month OLE enrolled 91 patients who completed the lead-in TPIP PAH Phase 2b study (NCT05147805) across 45 global sites. Following a 3-week blinded titration period, patients in the TPIP Continued group (

 = 60) resumed their achieved Phase 2b dose, while patients in the Placebo Crossed group (

 = 31) titrated from 80 µg once daily to a target of 640 µg or highest tolerated dose. Dose escalation to 1,280 µg once daily was permitted at investigator discretion. Efficacy outcomes were assessed against pre-randomization baseline values from the Phase 2b lead-in study.¹

The primary endpoint was long-term safety and tolerability. Secondary endpoints — including 6MWD, N-terminal pro-B-type natriuretic peptide (NT-proBNP), World Health Organization (WHO) Functional Class, and REVEAL Lite 2.0 risk score — were exploratory in nature.¹

At month 12, mean improvement from Phase 2b baseline in 6MWD was +55.7 meters in the TPIP Continued group and +54.1 meters in the Placebo Crossed group. NT-proBNP concentration was reduced by approximately 60% in both groups, with geometric mean ratios to baseline of 0.40 and 0.41, respectively. WHO Functional Class I or II was achieved in 78.3% of the TPIP Continued group and 80.6% of the Placebo Crossed group; more than 25% of patients across both groups achieved WHO Functional Class I.¹

Mean REVEAL Lite 2.0 score improved by 2.0 points from baseline in the TPIP Continued group and 1.4 points in the Placebo Crossed group. Approximately 65% of patients across both groups achieved Refined Low Risk status, associated in prior REVEAL Lite 2.0 validation studies with an estimated 3-year mortality risk below 5% and approximately 7% risk of clinical worsening at 1 year.¹

"The REVEAL Lite 2.0 risk score provides a powerful, non-invasive way to track disease trajectory," said Raymond Benza, MD, George M. and Linda H. Kaufman Academic Chair of Cardiology at Sentara Health, and Phase 2b steering committee member. "Previous REVEAL Lite 2.0 validation showed that a 1-point score improvement reduces risk of mortality by 23% and reduces the risk of clinical worsening by 21%. Here we saw that patients on TPIP averaged a greater than 1-point improvement from baseline, which is really meaningful for patients."¹

Promising Results Tempered by High AE Rates and OLE Limitations

Treatment-emergent adverse events (TEAEs) occurred in 89.0% of patients through month 12. Serious TEAEs were reported in 18.7% and severe TEAEs in 16.5% of patients; 7.7% discontinued due to TEAEs. There were 4 deaths, none considered related to TPIP. The most common TEAEs occurring in ≥5% of patients were headache (28.6%), cough (15.4%), nasopharyngitis (14.3%), diarrhea (11.0%), upper respiratory tract infection (9.9%), bronchitis (7.7%), dizziness (6.6%), epistaxis (6.6%), nausea (6.6%), anemia (5.5%), influenza (5.5%), and pneumonia (5.5%). No new safety signals were identified at doses up to 1,280 µg.¹

Nicholas Kolaitis, MD, MS, associate professor of medicine at the University of California – San Francisco, previously addressed high AE rates with TPIP in data from a different study, noting that “[while] it seems like even though patients do have cough, [it] was not worse after starting this new formulation, which has allowed us to get to higher doses faster, and to higher doses in general… And I think that the big implication here is that it's easier to tolerate, it's easy to use. You can get to higher doses faster, so you can impact change a lot quicker in your patients, which potentially could lead to better outcomes down the line.”

Clinicians should note that this OLE is a single-arm, open-label study without a concurrent placebo control group; secondary and exploratory efficacy endpoints are not adjusted for multiplicity, and improvements reflect comparison to Phase 2b pre-randomization baseline values — meaning the TPIP Continued group's 12-month gains encompass the full treatment period beginning in the Phase 2b study, not a fresh OLE starting point. The sample sizes are small, and Insmed acknowledges that OLE data may not accurately predict results in the Phase 3 PALM-PAH randomized trial.¹ Full publication of the 12-month OLE data is planned.

These results build on Phase 2b data reported in June 2025, in which TPIP produced a 35% placebo-adjusted reduction in pulmonary vascular resistance at week 16 (least squares mean ratio, 0.65; 

 <.001) and a 35.5-meter improvement in 6MWD versus placebo.²

Insmed Incorporated. Insmed announces positive 12-month data from the ongoing open-label extension study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension. Press release. July 16, 2026. https://investor.insmed.com/2026-07-16-Insmed-Announces-Positive-12-Month-Data-from-the-Ongoing-Open-Label-Extension-Study-of-Treprostinil-Palmitil-Inhalation-Powder-TPIP-in-Patients-with-Pulmonary-Arterial-Hypertension

Insmed Incorporated. Insmed announces positive topline results from Phase 2b study of treprostinil palmitil inhalation powder (TPIP) as once-daily therapy in patients with pulmonary arterial hypertension. Press release. June 10, 2025. https://investor.insmed.com/2025-06-10-Insmed-Announces-Positive-Topline-Results-from-Phase-2b-Study-of-Treprostinil-Palmitil-Inhalation-Powder-TPIP-as-Once-Daily-Therapy-in-Patients-with-Pulmonary-Arterial-Hypertension

Treprostinil palmitil inhalation powder, a once-daily dry powder prostanoid prodrug, produced sustained 12‑month improvements in exercise capacity, biomarkers, functional class, and risk status in a 24‑month open-label extension enrolling 91 PAH patients. Participants crossing over from placebo achieved efficacy similar to continuous TPIP, consistent with benefit after delayed initiation. Mean 6MWD increased ~55 m and NT‑proBNP fell ~60%, with ~65% reaching Refined Low Risk by REVEAL Lite 2.0. Safety showed frequent TEAEs without new signals.

New data support advancement of the Phase 3 PALM-PAH trial, a randomized, double-blind, placebo-controlled study now enrolling, with change in 6MWD as its primary endpoint.

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Daily Inhaled TPIP Improved PAH Measures at 12 Months in OLE

Rajiv Agarwal, MD, MS, is a Professor Emeritus of Medicine at Indiana University School of Medicine and VA Medical Centre in Indianaoplis.

FIND-CKD Trial Poses Finerenone as a "Third Pillar" for Nondiabetic CKD

Finerenone (Kerendia), a nonsteroidal mineralocorticoid receptor antagonist (MRA) already approved for 

 slowed the rate of kidney function decline in adults with CKD who did not have diabetes, according to results of the phase 3 FIND-CKD trial published in the New England Journal of Medicine.

Rajiv Agarwal, MD, professor emeritus of medicine at Indiana University School of Medicine and staff physician at the Richard L. Roudebush VA Medical Center, frames finerenone as completing a trio of complementary mechanisms: RAS inhibitors work hemodynamically, SGLT2 inhibitors act on tubular and metabolic pathways, and finerenone targets inflammation and fibrosis. Together, he said, they may now function as 3 distinct pillars of CKD care.

 Nondiabetic CKD, phase 3 FIND-CKD (n=1584)

 22% reduction in heart failure hospitalization, 18% reduction in CV death

While you’re here, check out part 1 of our conversation with Agarwal:

https://www.hcplive.com/view/find-ckd-expands-finerenone-evidence-beyond-diabetic-ckd-with-rajiv-agarwal-md

How Much Did Finerenone Slow Kidney Decline?

Agarwal and colleagues randomly assigned 1584 adults with CKD and albuminuria who were already taking a renin–angiotensin system (RAS) inhibitor to finerenone, 10 or 20 mg daily, or placebo.

At baseline, participants had an eGFR of 25 to less than 90 mL/min/1.73 m² and a urinary albumin-to-creatinine ratio of 200 to 3500, with a similar mean baseline eGFR between groups, at roughly 47 mL/min/1.73 m².

Over 32 months, the mean annual rate of change in eGFR, the trial's primary outcome, was −3.3 mL/min/1.73 m² with finerenone compared with −4.0 mL/min/1.73 m² with placebo, a difference of 0.7 mL/min/1.73 m² (95% CI, 0.3-1.1; 

A prespecified hierarchical analysis also showed a reduced risk of a composite kidney or cardiovascular outcome, defined as a sustained eGFR decline of at least 57%, kidney failure, heart failure hospitalization, or cardiovascular death, with finerenone versus placebo (hazard ratio, 0.77; 95% CI, 0.60-0.99; P = .04).

Does Finerenone Reduce Cardiovascular Events? What the Pooled Infinity Analysis Adds

In FIND-CKD alone, the cardiovascular composite trended favorably but did not reach statistical significance on its own (hazard ratio, 0.60; 95% CI, 0.27-1.33). A larger pooled analysis, Infinity, combining FIND-CKD with finerenone's prior diabetic CKD trials, filled in that picture: heart failure hospitalization and cardiovascular death were each independently, statistically significant, with reductions of 22% and 18%, respectively.

Notably, cardiovascular death reached nominal significance in the pooled analysis after narrowly missing it in an earlier pooled analysis limited to diabetic CKD trials (

= .076). Agarwal said this pattern, along with a parallel signal for all-cause mortality, represents a mortality benefit worth continued follow-up, since both cardiovascular and all-cause mortality comparisons were nominally significant across the pooled cohort.

Agarwal said the Infinity data support positioning finerenone as a foundational therapy to be layered in early alongside RAS and SGLT2 inhibitors, rather than reserved as a later-line option.

Finerenone selectively blocks the mineralocorticoid receptor, a pathway implicated in inflammation and fibrosis across multiple kidney disease etiologies, independent of glycemic status. 

The agent was first approved by the FDA in 2021 for adults with CKD associated with type 2 diabetes, based on the FIDELIO-DKD trial, which showed reduced risk of CKD progression and cardiovascular events compared with placebo in that population. 

FIND-CKD extends that evidence base to CKD without diabetes, a population that historically has had fewer disease-modifying options despite representing a substantial share of overall CKD cases.

What's Next: The SGLT2 Combination Question

Only about 17% of FIND-CKD participants were using an SGLT2 inhibitor at baseline, leaving the finerenone–SGLT2 inhibitor combination in nondiabetic CKD an open question. 

Of the roughly 14,500 participants in the Infinity pooled analysis, only about 1500 came from FIND-CKD itself, meaning the hard-outcome evidence in nondiabetic CKD still leans heavily on the diabetic trials within the pool. Agarwal pointed to a need for prospective combination data, including potassium and volume effects, adequately powered biopsy-confirmed studies in IgA nephropathy and FSGS, longer-term safety and durability data, and biomarker work to identify which patients benefit most.

Editor’s Note: Agarwal reports relevant disclosures with Alexion Pharmaceuticals, Inc. AstraZeneca, Bayer HealthCare Pharmaceuticals Inc., Boehringer Ingelheim, and others.

Heerspink HJL, Neuen BL, Agarwal R, et al. Finerenone in persons with chronic kidney disease without diabetes. N Engl J Med. Published online June 4, 2026. doi:10.1056/NEJMoa2604625

Neuen BL, Heerspink HJL, Perkovic V, et al. Efficacy and safety of finerenone in patients with chronic kidney disease: an individual participant data pooled analysis (INFINITY). Lancet. 2026;407(10546):2375-2386. doi:10.1016/S0140-6736(26)01009-3

Bakris GL, Agarwal R, Anker SD, et al. Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med. 2020;383:2219-2229. doi:10.1056/NEJMoa2025845

Bayer. Phase III FIND-CKD results show Bayer's Kerendia (finerenone) improved eGFR slope and reduced risk of a composite kidney-cardiovascular outcome in adults with non-diabetic chronic kidney disease. Press release. June 5, 2026. 

https://www.bayer.com/en/us/news-stories/kerendia-for-non-diabetic-chronic-kidney-disease

Phase 3 FIND-CKD data show finerenone slows kidney decline and reduces CV events in adults with nondiabetic CKD, Rajiv Agarwal, MD, adds his perspective. 


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Boadie Dunlop, MSC, professor and chair of psychiatry and health behavior at the Medical College of Georgia at Augusta University.

New 26-week COMP006 data show durable MADRS improvement after 2 COMP360 psilocybin doses in treatment-resistant depression, Dunlop explains.

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Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

What New 26-Week COMP006 Data Mean for TRD, With Boadie Dunlop, MD

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

FDA approved once-daily oral enlicitide to lower LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

FDA News

FDA Approves Enlicitide for LDL-C Lowering in Adults With Hypercholesterolemia

Saakshi Khattri, MD, is a board certified Dermatologist, Rheumatologist and Internist and one of only a handful of triple board-certified physicians across the US.

Saakshi Khattri, MD, reviews 5-year extension data of risankizumab in psoriatic arthritis, emphasizing sustained radiographic non-progression and durability of clinical response.

Video Series

5-Year Radiographic Outcomes With Risankizumab in Psoriatic Arthritis: KEEPsAKE 1 Data

Kathleen Cook Suozzi, MD, is an associate professor of Dermatology and the director of Aesthetic Dermatology at the Yale School of Medicine. She specializes in Mohs micrographic surgery to treat skin cancer and uses lasers and photodynamic therapy to reverse sun damage.

In this discussion during UV Safety Awareness Month, Suozzi highlights tips on reversing photodamage and sun protection misconceptions.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

What Are the Biggest Sunscreen Misconceptions? With Kathleen Suozzi, MD

These modifiable factors, among others, directly contribute to 88.7% of all IHD deaths in 2023.

Structural Heart Disease

BMI, Fasting Plasma Glucose Lead Ischemic Heart Disease Mortality in US

Massie, Donnelly, and Mankowski discuss how transplant center choice shapes kidney transplant evaluation and access.

David Price, professor of primary care respiratory medicine at the University of Aberdeen.

Preliminary real-world data presented at EAACI 2026 found broad reductions in respiratory tract infections with OM-85, David Price, MD, said.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Seasonal Allergy

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

OM-85 Reduces Recurrent RTIs Across Age Groups in Real-World REACH

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

These positive topline findings highlight the investigational TYK2 inhibitor soficitinib (ICP-332) in patients with moderate-to-severe atopic dermatitis.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

New Phase 3 Data Suggest Soficitinib Meets Primary Endpoint for Atopic Dermatitis

New data from the 45-patient Midpoint Cohort, despite not being powered for statistical significance, indicate a potentially substantial benefit.

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

REMAIN-1: Improved GLP-1-Induced Weight Loss Retention With Revita DMR System

Alex Hillenbrand is an assistant editor for 

FDA grants priority review to obinutuzumab, positioning it as the first potential approved therapy for primary membranous nephropathy.

Latest News

Don’t Forget to Follow Up After Kidney Transplant Referral

Diagnosing and Treating Familial Chylomicronemia Syndrome: Perspectives from a Clinical Forum

New Martin-Hopkins LDL-C-Estimating Equation Simplifies Implementation for Comparable Results

Daily Inhaled TPIP Improved PAH Measures at 12 Months in OLE

FIND-CKD Trial Poses Finerenone as a "Third Pillar" for Nondiabetic CKD