Scott Wenderfer, MD, PhD, is Division Head of Nephrology at BC Children's Hospital Research Institute (BCCHR) and Clinical Professor in the Department of Pediatrics at the University of British Columbia.

Myda Khalid, MD, is Associate Professor of Clinical Pediatrics and Program Director of Pediatric Nephrology Fellowship Program at IU School of Medicine.

Children with glomerular diseases have historically had fewer therapies developed and tested on their behalf than adults, leaving pediatric nephrologists to extrapolate safety and efficacy from adult data. As targeted agents move through adult pipelines, pediatric glomerular disease clinical trials are beginning to catch up.

Myda Khalid, MD, of Riley Hospital for Children at Indiana University, and Scott Wenderfer, MD, PhD, of BC Children’s Hospital and the University of British Columbia, co-chairs of the 

International Society of Glomerular Disease (ISGD)

 about the obstacles and how the field is addressing them.¹

Why Children Have Been Left Out of Glomerular Disease Trials

What Has Held Back Pediatric Glomerular Disease Trials?

Wenderfer pointed to a longstanding tendency to protect children from research, which effectively barred them from trials. As a result, pediatric nephrology practice has largely relied on adapting adult safety and efficacy findings.

“Now rather than protecting them from research, we’re advocating for them to be involved with research,” Wenderfer said. He noted trial participants receive closer follow-up and more safeguards than in routine care, and drugs can work well and safely in children even when they are less effective or less safe in adults.

Khalid said the trials simply were not available until recently. Regulators, scientists, physicians, and patient organizations have since pushed for pediatric inclusion, and the number of pediatric trials is rising.

Wenderfer, whose work centers on lupus nephritis, said the lack of trials has limited the evidence behind pediatric consensus treatment plans. Khalid, who runs a glomerular disease research clinic at Riley, recalled a young patient who regularly asked when she would receive a medicine specific to her disease.

Which Assumptions About Pediatric Trial Participation Proved Wrong?

Drawing on her IgA nephropathy trial experience, Khalid described several assumptions disproven in her clinic. Parents were not unwilling to enroll their children once trust was established.

“I realized it was important for me as their physician and for us as a community to teach people about the disease, to teach them about the science, to bring them to a place of trust in the physician team,” Khalid said.

Distance has not been a barrier, as most of her trial patients drive about three hours to reach her center. Vulnerability indices such as income and household size did not predict participation, and retention has been strong.

Families value consistent coordinators, facilities, and physicians, which creates a routine and individualized care. Khalid said she once expected trials to feel like a burden, but many families told her they were grateful to be part of something bigger.

Wenderfer highlighted pediatric-specific requirements, including child assent, reassent as children mature, and transition to consent at the age of majority. Institutional review boards also apply added protections for children as a vulnerable population.

How Can Pediatric Nephrologists Get Involved in Glomerular Disease Trials?

Wenderfer said some trials now enroll children and adults together from the start. Others begin pediatric enrollment only after an adult trial succeeds, often starting with older adolescents and moving to younger age groups after data safety monitoring board review.

Khalid leads the PIONEER basket trial at Riley, which enrolls both children and adults with glomerular diseases.² Wenderfer said pediatric nephrologists can contribute beyond serving as site investigators, including protocol development, data safety monitoring boards, and industry roles.

Promoting equitable trial access in underrepresented regions is one of four core GD-Kids goals.¹ Wenderfer noted the working group includes members from North America, Europe, Japan, Hong Kong, and India, with plans to expand into South America and Africa.¹

Khalid said some newer agents may eventually allow clinicians to offer patients the prospect of disease elimination. Wenderfer said he hopes GD-Kids will draw more colleagues into clinical trial research.

International Society of Glomerular Disease. International Society of Glomerular Disease launches GD-Kids to advance pediatric glomerular medicine worldwide. Published October 15, 2026. Accessed November 14, 2026. 

https://www.is-gd.org/en/news-from-isgd/a-global-effort-to-move-pediatric-glomerular-medicine-forward

Lucas S. First pediatric patient in the world enrolled in PIONEER clinical trial for kidney glomerular disease at IU School of Medicine. Indiana University School of Medicine. Published April 30, 2026. Accessed November 14, 2026. 

https://medicine.iu.edu/news/2026/04/kidney-glomerular-disease-trial

Videos

Myda Khalid, MD, and Scott Wenderfer, MD, PhD, discuss barriers to pediatric glomerular disease clinical trials and the myths they have seen disproven.

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Strategic Alliance Partnership

Overcoming Barriers to Pediatric Glomerular Disease Clinical Trials

William Lumry, MD: Founder of the Allergy & Asthma Specialists of Dallas

Lanadelumab (Takhzyro) prophylaxis was associated with improved quality of life (QoL) for children with 

 and their caregivers, according to a retrospective registry analysis presented at the 

American College of Allergy, Asthma and Immunology (ACAAI) 2026 Annual Scientific Meeting

The US Food and Drug Administration (FDA) expanded the lanadelumab label to include patients aged 2 to <12 years in February 2023, based on the open-label phase 3 SPRING study and efficacy data extrapolated from the phase 3 HELP study.²˒³ SPRING reported large gains in caregiver-reported Pediatric Quality of Life Inventory (PedsQL) scores across 52 weeks of treatment.² The new analysis, presented as a late-breaker by William R. Lumry, MD, examines how long-term prophylaxis affects QoL and caregiving burden in routine practice.¹

“It was just a complete flip in what the patients and the caregivers perceived as far as their quality of life with treatment,” said Lumry, a clinical professor of internal medicine at the University of Texas Southwestern Medical School in Dallas, in an interview with 

Lanadelumab Improves Quality of Life for Children With HAE and Caregivers

Lanadelumab Quality of Life Outcomes in the PIONEER HAE Registry

Investigators identified patients aged 2 to < 18 years at lanadelumab initiation, along with their caregivers, through the TRIO Health Consortium of Independent Immunology Clinics (CIIC) PIONEER HAE registry.¹ Caregivers completed a cross-sectional survey including the PedsQL and the PedsQL Family Impact Module (FIM), each scored 0 to 100, with greater scores indicating better QoL. The survey captured the 12 months before lanadelumab initiation and the most recent 3 months of treatment.¹

Eleven caregivers (mean age, 42.3 years; 64% female) reported on 13 pediatric patients (mean age, 12.2 years; 62% male).¹ Patients started lanadelumab at a mean age of 8.9 years and received treatment for a mean of 3.7 years.

On a 5-point scale (1 = poor; 5 = excellent), caregiver-perceived patient QoL improved from a mean of 2.2 before lanadelumab to 4.7 during the current period.¹ Caregiver-perceived caregiver QoL improved from 1.9 to 4.5. During treatment, mean PedsQL total scores were 68.5 for patients aged 5 to 7 years, 91 for those aged 8 to 12 years, and 84 for those aged 13 to 18 years.¹

Caregiver Burden, Work, and Daily Activities With Lanadelumab

Caregiver-perceived patient QoL improved from 2.2 to 4.7 and caregiver QoL from 1.9 to 4.5 on a 5-point scale with lanadelumab.

69% of caregivers reported no work or daily activity impact during treatment, vs 23% and 8%, respectively, before lanadelumab.

Communication and worry about unpredictable attacks did not change significantly, according to Lumry.

During the current treatment period, 69% of caregivers reported no impact of their child’s HAE on work or daily activities.¹ Before lanadelumab, only 23% reported no work impact and 8% reported no daily activity impact. Lumry noted 68% of caregivers had to request flexibility, stop working, or make other adjustments before their child began prophylaxis.

PedsQL-FIM scores during treatment were 92 (SD, 13) for family functioning and 90 (SD, 20) for daily activities.¹ According to Lumry, the proportion of caregivers reporting impaired sleep fell from 85% before treatment to 31% during treatment. Reported impact on recreational activities dropped from 62% to 8%, with an identical shift for work responsibilities.

Errands, household chores, and family time affected 30% to 45% of caregivers before lanadelumab, with no reported impact during treatment, Lumry said. He noted 2 FIM domains, communication and worry about unpredictable attacks, did not change significantly with treatment.

“The study provides a really great multidimensional assessment of the broader impact of this very effective treatment in pediatric patients and in their caregivers,” Lumry said.

Watch part 1 of our interview with Lumry here: 

Lanadelumab Reduces Pediatric HAE Attacks 95% in Real-World Analysis

Editor’s note: Reported disclosures for Lumry include Novartis Pharmaceuticals Corporation, CSL Behring, Takeda Pharmaceuticals U.S.A., Inc., BioCryst US Sales Co., LLC, and more.

Driscoll Shempp P, Lumry W, Duran V, et al. Impact of lanadelumab prophylaxis on quality of life in pediatric hereditary angioedema patients and caregivers. Presented at: American College of Allergy, Asthma and Immunology 2026 Annual Scientific Meeting; November 12-16, 2026; Phoenix, AZ.

Maurer M, Lumry WR, Li HH, et al. Lanadelumab in patients 2 to less than 12 years old with hereditary angioedema: results from the phase 3 SPRING study. 

FDA expands lanadelumab for preventing HAE attacks in younger children. 

https://www.hcplive.com/view/fda-expands-lanadelumab-preventing-hae-attacks-younger-children

. HCPLive. Published February 3, 2023. Accessed November 14, 2026.

Caregiver-rated QoL rose from 1.9 to 4.5 on a 5-point scale with lanadelumab prophylaxis in a pediatric HAE registry analysis, William Lumry, MD, said.

Allergy

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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 various hobbies. You can reach her at vjohnson@mjhlifesciences.com.

 (EoE) treated with dupilumab before age 6 years had about half the incidence of asthma 3.5 years later compared with matched children who never received the biologic, according to a retrospective cohort study presented at the 

American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting

 in Phoenix, held November 12 to 16, 2026.

Dupilumab, a monoclonal antibody inhibiting interleukin 4 and interleukin 13 signaling, is the only FDA-approved biologic for EoE and is approved for patients as young as 1 year, but its asthma indication begins at age 6 years.

 Kayla J. Steinberger, MD, PhD, resident physician, Department of Pediatrics at West Virginia University, used this gap between approved ages to assess whether dupilumab given for EoE early in childhood was associated with later asthma.

"Targeting the shared T2 inflammatory pathway early may influence subsequent atopic disease development, not just treat individual conditions," Steinberger wrote.

TriNetX cohort design and propensity matching

Using the TriNetX network, Steinberger identified children diagnosed with EoE at age 6 years or younger between January 1, 2016, and January 1, 2026.

 The treated group received dupilumab for EoE and then was off the drug for at least 1 year, and the comparator group had never received dupilumab. Children with an asthma diagnosis at age 6 years or younger were excluded.

Is dupilumab approved for young children with EoE?

Yes. Dupilumab is approved for EoE in patients as young as 1 year, while its asthma indication begins at age 6 years.

Among 698 propensity-matched pairs, incident asthma at 3.5 years was 8.1% with early dupilumab vs 16.0% without it, an absolute risk reduction of 7.9 percentage points.

Does this show dupilumab prevents asthma?

No. The retrospective design shows an association only, and prospective studies would be needed to determine whether early dupilumab changes atopic disease progression.

After 1:1 propensity score matching on age, sex, race, asthma diagnosis, and atopic dermatitis diagnosis, each group included 698 children.

 Mean age at index was 3.2 years in both groups, about 74% were male, and 46.0% of each group had atopic dermatitis.

At 3.5 years after the index event, incident asthma occurred in 8.1% of dupilumab-treated children vs 16.0% of never-treated children.

 This corresponded to an absolute risk reduction of 7.9 percentage points (95% CI, 3.8–12.1; 

Steinberger noted the lower incidence persisted 3.5 years after the index event even though treated children had been off dupilumab for at least 1 year.

 She concluded early targeted biologic therapy may reduce incident asthma in children with EoE and may modify the trajectory of atopic disease.

The study was retrospective and relied on electronic health record data, so it cannot establish causation. The poster did not report dupilumab dosing, treatment duration, EoE severity, or safety outcomes, and residual confounding by indication between treated and untreated children cannot be excluded.

Steinberger KJ. Early dupilumab treatment for pediatric eosinophilic esophagitis is associated with reduced incident asthma. Presented at: American College of Allergy, Asthma & Immunology 2026 Annual Scientific Meeting; November 12-16, 2026; Phoenix, AZ.

Chehade M, Dellon ES, Spergel JM, et al. Dupilumab for eosinophilic esophagitis in patients 1 to 11 years of age. 

. 2024;390(24):2239-2251. doi:10.1056/NEJMoa2312282

Articles

Early dupilumab exposure for eosinophilic esophagitis (EoE) in children ≤6 years was associated with a substantially lower subsequent asthma incidence over 3.5 years versus propensity-matched peers never receiving dupilumab. Using TriNetX EHR data, incident asthma occurred in 8.1% of treated patients versus 16.0% of comparators, yielding a 7.9-point absolute risk reduction. The association persisted despite at least 1 year off therapy, supporting a potential disease-modifying effect on the shared type 2 inflammatory axis. Retrospective design and residual confounding limit causal inference.

Children with eosinophilic esophagitis treated with dupilumab before age 6 had about half the asthma incidence of matched untreated peers 3.5 years later.

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Early Dupilumab in Pediatric EoE Tied to Lower Incident Asthma

Pediatric glomerular disease clinical trials have long trailed adult research, leaving pediatric nephrologists with few trained investigators, limited infrastructure, and little formal guidance on how to start. The 

 formed the GD-Kids working group in 2026 to help close this gap.¹

At the inaugural ISGD Clinical Trials Summit in Galveston, Texas, co-chairs Myda Khalid, MD, of Riley Hospital for Children at Indiana University, and Scott Wenderfer, MD, PhD, of BC Children’s Hospital and the University of British Columbia, spoke with 

 about why the group was needed and how it is training the next generation of investigators.

Training the Next Generation of Pediatric Glomerular Disease Trialists | GD-Kids

Khalid said new glomerular disease therapies developed for adults are now beginning to expand into children. GD-Kids gives physicians, sponsors, patients, and others in the space a shared platform to improve how pediatric trials are run.

Why Do Pediatric Nephrologists Need a Dedicated Glomerular Disease Trials Group?

Wenderfer described GD-Kids as a home for pediatric nephrologists interested in glomerular disease. He said pediatric investigators needed a society to advocate for their priorities, and ISGD’s emphasis on pediatric trials drew him to the working group.

Khalid noted the group’s international makeup quickly became one of its strengths. She said she has already learned from colleagues in Asia and Europe and hopes to draw on other regions as the group grows.

ISGD has outlined 4 core goals for GD-Kids: building global pediatric trial capacity, strengthening collaboration across institutions and regions, promoting equitable trial access in underrepresented regions, and developing shared best practices for trial design, start-up, and execution.¹ Initial priorities include a global survey of experienced investigators and sites to identify barriers and needed resources.¹

Efforts such as the PIONEER pediatric gateway initiative have similarly sought earlier integration of children into glomerular disease drug development.²

How Are Clinical Trial Boot Camps Preparing Pediatric Investigators?

GD-Kids grew out of ISGD’s first Clinical Trials Bootcamp, held during the 2025 European Society for Paediatric Nephrology (ESPN) meeting in Athens, Greece.¹ Khalid said the program targeted fellows, trainees, and junior faculty. It introduced basic clinical trial concepts, common challenges, and strategies to overcome them while building a community of early-career investigators.

A second boot camp followed in Miami in partnership with the Pediatric Nephrology Research Consortium, at a meeting focused on trainees. Khalid and Wenderfer both participated in a more recent boot camp in Bordeaux, France, and a combined ISGD and ESPN boot camp is planned for Florence, Italy, next year.

Wenderfer noted many ESPN juniors return to the boot camps year after year. This allows faculty to build on prior sessions and help attendees grow more comfortable in the glomerular disease space over time.

Khalid recalled starting clinical trial work 8 to 10 years ago, when only a handful of pediatric nephrologists were running trials.

“I remember asking people, ‘Hey, does anybody know how to do these? Is there a booklet? Do I know where to start?’ And in fact, I couldn’t find an answer,” Khalid said.

She said the boot camps could help the field compile a formal curriculum and a faculty network newcomers can turn to.

Wenderfer said many clinicians want to participate in research and give their patients access to innovative therapies but do not know where to begin. He added fellows in particular struggle to find clinical trial exposure during academic training, and the boot camps offer an early entry point.

Gipson DS, Tarnoff J, Lee L, et al. A pediatric gateway initiative for glomerular disease: introducing PIONEER. Kidney Int. 2021;99(3):515-518. doi:10.1016/j.kint.2020.11.013

Myda Khalid, MD, and Scott Wenderfer, MD, PhD, explain how ISGD’s GD-Kids group and its clinical trial boot camps aim to build pediatric glomerular disease research capacity.

Building A Global Network for Pediatric Glomerular Disease Clinical Trials

 show lanadelumab (Takhzyro) prophylaxis reduced attack frequency by 95% in pediatric patients with 

, according to a retrospective chart review.

Before the US Food and Drug Administration (FDA) expanded the lanadelumab label to children aged ≥ 2 years in February 2023, routine prophylaxis for children aged 6 to <12 years required dosing every 3 to 4 days, and no prophylactic option was approved for children aged 2 to 5 years.

 The expanded approval was supported by safety, pharmacokinetic, and pharmacodynamic data from the phase 3 SPRING study, along with efficacy data extrapolated from the phase 3 HELP study.

“If a child had an attack, they’d have to go to the emergency room, get an IV started, get treated,” said William R. Lumry, MD, clinical professor of internal medicine at UT Southwestern Medical Center. “It was a big deal.”

Lanadelumab Effectiveness in Pediatric HAE: Real-World Attack Rates

The analysis drew on patient records from a 1-year baseline period before lanadelumab initiation, followed by a post-initiation period capturing attack frequency, severity, and resolution. Investigators also assessed health-related quality of life in treated patients. The cohort included 13 patients aged < 18 years.

Approximately 40% of patients were aged 6 to 12 years, and approximately 60% were aged 12 to 18 years. Most were male, most had type 1 HAE, and most were White. Patients initiated lanadelumab at varying points in their disease course, including after diagnosis, after a hospitalization, or after first symptom onset.

During the baseline period, patients experienced approximately 1 attack every 2 months. After lanadelumab initiation, attack frequency fell by 95%.

“So basically, [participants had] no attacks,” Lumry said. “Maybe 1 attack a year at [the] very most.”

Baseline attacks were frequently abdominal or peripheral, affecting the hands and feet. Some patients also reported facial, genital, and airway attacks.

Before treatment, most attacks required on-demand therapy, and few resolved without intervention. After lanadelumab initiation, 100% of patients reported attacks resolving without on-demand therapy.

The real-world findings align with results from the phase 3 SPRING study, an open-label, multicenter trial of lanadelumab in 21 patients aged 2 to <12 years.

 In SPRING, the mean attack rate decreased by 94.8% from baseline (1.84 to 0.08 attacks per month), and 76.2% of patients were attack-free during the 52-week treatment period. No serious treatment-emergent adverse events or discontinuations due to such events occurred, and injection site pain was the most common treatment-emergent adverse event.

Lumry W, et al. Clinical Outcomes and Treatment Experiences Among Pediatric Hereditary Angioedema Patients Receiving Lanadelumab Prophylaxis. Presented at the American College of Allergy, Asthma and Immunology 2026 Annual Scientific Meeting; November 12-16, 2026; Phoenix, AZ.

US FDA approves Takeda’s Takhzyro (lanadelumab-flyo) to prevent hereditary angioedema (HAE) attacks in children 2 years of age and older. Takeda. Published February 3, 2023. Accessed November 12, 2026. 

https://www.takeda.com/newsroom/newsreleases/2023/us-fda-approves-takedas-takhzyro-lanadelumab-flyo-to-prevent-hereditary-angioedema-hae-attacks-in-children-2-years-of-age-and-older/

William R. Lumry, MD, reports a 95% drop in attack frequency after lanadelumab initiation in a real-world chart review of 13 pediatric patients with HAE.

Dareen Siri, MD, discusses remibrutinib's approval in symptomatic dermographism and RemIND data across chronic inducible urticaria.

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Remibrutinib Doubles Dermographism Responses: Dareen Siri, MD

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

No patients with alpha-gal syndrome needed epinephrine for a food reaction during omalizumab therapy in a 64-patient cohort presented at ACAAI 2026.

Omalizumab Linked to 0 Epinephrine Use in Alpha-Gal Syndrome

Podcasts

Suceena Alexander, MD, joins Brendon Neuen, MBBS, PhD, and Shikha Wadhwani, MD, MS, to discuss platform trial design in IgA nephropathy and beyond.

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Kidney Compass: Platform Trials in IgA Nephropathy and Glomerular Disease

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.

Approval of obinutuzumab for adults with PMN follows MAJESTY, where 37% vs 6% achieved complete remission at week 104 vs tacrolimus.

FDA News

FDA Approves Obinutuzumab (Gazyva) for Primary Membranous Nephropathy

A post hoc, unmatched comparison presented at ACAAI 2026 found similar 14-day improvements in urticaria activity with omalizumab vs remibrutinib.

Omalizumab, Remibrutinib Show Similar Early CSU Gains in Indirect Analysis

Thanai Pongdee, MD, discusses 4-year PIONEER symptom data with avapritinib, skin-symptom findings, and the PANORAMA-US study in ISM at ACAAI 2026.

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Fewer Severe ISM Symptoms After 4 Years of Avapritinib: Thanai Pongdee, MD

David Golden, MD, clinical associate professor of medicine at Johns Hopkins University School of Medicine.

In the lowest Cmax tertile, AQST-109 produced greater, faster blood pressure responses than epinephrine auto-injectors or intramuscular epinephrine, David Golden, MD, said.

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AQST-109 Sublingual Epinephrine Holds Up at Low Systemic Exposure

Nancy Reau, MD, is Professor of Internal Medicine, Richard B. Capps Chair of Hepatology, Associate Director of Solid Organ Transplantation, and Section Chief of Hepatology at Rush University Medical Center.

Nancy Reau, MD, discusses ECLIPSE 1 data showing monthly elebsiran plus tobevibart achieved undetectable HDV RNA in 79% of patients with hepatitis delta.

Hepatology

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What ECLIPSE 1 Means for Hepatitis Delta Treatment, With Nancy Reau, MD

Michael S. Blaiss, MD, clinical professor at the Medical College of Georgia at Augusta University.

Systolic blood pressure rose about 22 mm Hg with double-dose FMXIN002 vs 6 mm Hg with an autoinjector, without cardiovascular adverse events.

Intranasal Epinephrine Powder Safety After Double Dose, With Michael Blaiss, MD

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for 

. He is also the executive producer of two podcasts: 

. 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.

Oral icotrokinra beat placebo and was noninferior to ustekinumab in moderate to severe plaque psoriasis in the phase 3 ICONIC-ASCEND trial.

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Latest News

Overcoming Barriers to Pediatric Glomerular Disease Clinical Trials

Lanadelumab Improves Quality of Life for Children With HAE and Caregivers

Early Dupilumab in Pediatric EoE Tied to Lower Incident Asthma

Building A Global Network for Pediatric Glomerular Disease Clinical Trials

Lanadelumab Reduces Pediatric HAE Attacks 95% in Real-World Analysis