Nephrology Month in Review: July 2024

July was a promising start to the second half of what has been a strong year in nephrology thus far. Characterized by US Food and Drug Administration news and other renal pipeline updates, new guidelines from the American Kidney Fund, and prognostic research in IgA nephropathy (IgAN), our July 2024 month in review spotlights some of HCPLive’s top coverage from the past few weeks.

Pipeline Updates

FDA Accepts sNDA for Furosemide (Furoscix) in Chronic Kidney Disease

The lone major renal pipeline update in July was the FDA’s acceptance of a supplemental New Drug Application (sNDA) from scPharmaceuticals to expand the indication for furosemide (Furoscix) to include the treatment of edema due to fluid overload in patients with chronic kidney disease (CKD). Previous Type D meeting feedback indicated no additional clinical studies would be needed to expand the indication so long as scPharmaceuticals could demonstrate an adequate pharmacokinetic and pharmacodynamic bridge to the listed drug, furosemide injection 10 mg/mL.

With the acceptance of filing for the sNDA, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025.

ATEV Meets Primary Endpoints in Phase 3 Trial for Arteriovenous Access in Hemodialysis

Also in the nephrology pipeline is Humacyte’s acellular tissue engineered vessel (ATEV) in arteriovenous access for patients with end-stage renal disease, which saw positive topline results from a phase 3 trial announced in July. Results showed ATEV demonstrated superior function and patency at 6 and 12 months, the study’s co-primary endpoints, compared to autogenous fistula, which is the current standard of care for hemodialysis patients.

“We are thrilled to announce positive results for the Phase 3 V007 trial, which we believe highlight the potential of the ATEV to improve arteriovenous access in hemodialysis patients who are underserved by the current standard of care,” Laura Niklason, MD, PhD, chief executive officer of Humacyte, said in a press release. “We expect to discuss a potential market authorization pathway for the ATEV in hemodialysis access with the Food and Drug Administration soon. We also look forward to presenting more detailed results from the study, including subgroup analysis results, at upcoming medical conferences.”

Improving Renal Outcomes

SGLT2 Inhibitor, GLP-1 RA Combination Improves Cardiovascular, Kidney Outcomes in Diabetes

Findings from a recent meta-analysis examining 12 trials from the SGLT2 Inhibitor Meta-Analysis Cardio-Renal Trialists’ Consortium (SMART-C) including more than 70,000 patients with diabetes support the combination of SGLT2 inhibitors and GLP-1 receptor agonists for optimizing cardiovascular and kidney outcomes. Results suggest consistent effects of SGLT2 inhibitors on these outcomes, regardless of GLP-1 receptor agonist use.

Related: Brendon Neuen, MBBS, PhD: Optimizing Cardiorenal Prognosis with GLP-1, SGLT2 Combination

New Hyperkalemia Guidelines Help Patients with CKD Manage, Treat High Potassium

July saw the publication of new patient-focused guidelines from the American Kidney Fund for helping individuals with CKD manage and treat hyperkalemia. Developed with support from AstraZeneca, the guidance provides patients with tips on how to discuss high potassium with their health care provider, understand their potassium level, recognize symptoms of high potassium, and adhere to their treatment plan.

Related: Empowering Patients with Educational Resources for Kidney Disease, with Mike Spigler

IgA Nephropathy Prognosis

New IgA Nephropathy Machine Learning Models Show Promise for Diagnosis, Prognosis

Findings from this systematic review and meta-analysis suggest newer IgAN models generally outperform traditional ones, providing valuable insight into their comparative diagnostic and prognostic application values.

Metabolic Syndrome Linked to Renal, Cardiovascular Outcomes in IgA Nephropathy

In another notable piece of prognostic IgAN research from July, this study highlights the predictive value of body mass index, hyperuricemia, hypertension, and diabetes for determining the prognosis of IgAN. Findings suggest the importance of early risk stratification based on patients’ metabolic profiles.