Barbara Gillespie, MD, is Chief Medical and Strategy Officer of the International Society of Glomerular Disease and Adjunct Professor at the University of North Carolina.

Tobias Huber, MD, is President of the International Society of Glomerular Disease, Chair of the Center of Internal Medicine; Director of the III. Department of Medicine (Nephrology, Rheumatology, Endocrinology and Transplantation); and Director of the Hamburg Center for Kidney Health at the University Medical Center Hamburg-Eppendorf.

Clinical Trial Summit 2026: Advanced Therapies, Equity, and a Global Outlook for Glomerular Disease

The final episode looks ahead, weaving together summit planning, 2026 goals, cutting-edge therapies, and global equity.

Gillespie previews the International Society of Glomerular Disease (ISGD)’s inaugural Clinical Trial Summit in Galveston, Texas, organized with the University of Texas Medical Branch and leaders like Jochen Reiser, Vinay Gupta, and Shikha Wadhwani. Designed as a multi-stakeholder meeting, it will bring together basic scientists, trialists, venture capital, regulators, healthcare leaders, patients, study coordinators, and fellows. The format is intentionally interactive, aiming to break silos and “break barriers” in clinical trials.

Huber then proposes a “game” where each shares what they most look forward to by 2026. Their rapid-fire wishes include:

Implementing FSGS surrogate endpoints and widely sharing the work already completed.

Making substantial progress in membranous nephropathy endpoints, including integrating PLA2R titers into qualified surrogate measures.

Defining IgAN 2.0 trial designs as new drugs become standard of care, and learning how to combine multiple approved therapies targeting different points in the disease cascade.

Adapting hierarchical composite endpoints (HCEs) from cardiology, blending clinical outcomes, symptoms, and biomarkers to better reflect patient experience.

Advancing molecular stratification and endotyping of diseases via high-resolution tissue technologies, to eventually replace coarse histologic classifications.

The conversation then turns to cell and gene therapies, referencing an earlier KHI meeting with the 

 Center for Biologics Evaluation and Research (CBER) leaders and the approval of gene therapy for 

They anticipate cell therapies for diabetic kidney disease and membranous nephropathy, as well as gene therapy approaches for IgA nephropathy (IgAN) and Alport syndrome. They determine that success will require close collaboration with hematology and oncology teams already experienced with these modalities.

Huber closes with a reminder that all this high-end innovation must be matched by basic improvements in awareness and early detection, such as routine proteinuria screening, and by solutions for low- and middle-income countries. 

Gillespie adds a vision of glomerular disease centers of excellence, an idea long championed by her mentor Ron Falk, MD, and celebrates the growing cross-society collaboration that will be needed to turn glomerular disease into glomerular health worldwide.

, Chief Medical and Strategy Officer of the International Society of Glomerular Disease and Adjunct Professor at the University of North Carolina

, President of the International Society of Glomerular Disease, Chair of the Center of Internal Medicine; Director of the III. Department of Medicine (Nephrology, Rheumatology, Endocrinology and Transplantation); and Director of the Hamburg Center for Kidney Health at the University Medical Center Hamburg-Eppendorf

Editors’ Note: Gillespie reports no relevant disclosures. Huber reports relevant disclosures with Boehringer Ingelheim, Novartis, Alexion, Pfizer, Retrophin-Travere, and Fresenius Medical Care.

Gale D. RaDaR Validation Confirms PARASOL Findings on FSGS Surrogate Endpoint, with Daniel Gale, PhD, MB BChir. HCPLive. Published June 7, 2025. Accessed March 6, 2026. https://www.hcplive.com/view/radar-validation-confirms-parasol-findings-on-fsgs-surrogate-endpoint

Radhakrishnan J. New Guidelines and Novel Therapies in IgA Nephropathy, With Jai Radhakrishnan, MD. HCPLive. Published 2025. Accessed March 6, 2026. 

https://www.hcplive.com/view/new-guidelines-and-novel-therapies-in-iga-nephropathy-with-jai-radhakrishnan-md

Videos

Experts outline a 2026 vision for glomerular disease care, including new endpoints, combination therapies, and gene therapy advances.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Nephrology

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

IgA Nephropathy

The HCPLive Berger disease page is a resource for medical news and expert insights on IgA nephropathy. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in Berger disease, and more.

C3 Glomerulopathy

The HCPLive C3 glomerulopathy page is a resource for medical news and expert insights on C3G. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in C3G, and more.

Focal Segmental Glomerulosclerosis

The HCPLive focal segmental glomerulosclerosis page is a resource for medical news and expert insights on FSGS. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in FSGS, and more. 

Strategic Alliance Partnership

Clinical Trial Summit 2026: Advanced Therapies, Equity, Global Outlook For Glomerular Diseases

Parasol, Endpoints, and Rethinking Clinical Trials in Glomerular Disease

In this episode, the conversation broadens to the PARASOL framework and the evolving science of endpoints and trial design across glomerular diseases.

Gillespie briefly defines PARSOL, which is French for umbrella, as a unifying initiative conceived with leaders like Laurel Damashek to protect and guide the community toward better trial designs and therapeutic options across multiple diseases. PARASOL 1.0 focused on focal segmental glomerulosclerosis (FSGS), and newer extensions now target membranous nephropathy and APOL1-mediated kidney disease, with ambitions to cover many glomerular diseases over the coming decade.

The core philosophy of PARASOL is collaborative data sharing. For example, rather than each company independently shouldering the burden of building evidence for regulatory endpoints, sponsors with competing drugs work together, pooling clinical trial and registry data to evaluate potential surrogate endpoints. Barbara underscores the importance of this shift, echoing FDA voices like Lisa Thompson, MD, MBA, who advocate for collaboration as essential to progress in rare and complex diseases.

Gillespie then gives a concise tutorial on endpoints:

In regulatory terms, endpoints must reflect how a patient feels, functions, or survives.

Validated surrogate endpoints (e.g., LDL cholesterol in atherosclerotic disease) have strong, long-term data linking biomarker changes to clinical outcomes.

Reasonably likely surrogate endpoints support accelerated approval, such as proteinuria reductions in IgA nephropathy.

Candidate surrogate endpoints, the focus of Parasol, are being evaluated for their potential to move up the hierarchy.

She notes that while some sponsors try to copy-paste the IgA nephropathy (IgAN) “recipe” to other diseases, this is inappropriate because each glomerular disease has unique pathobiology and mechanisms of action. Hence, disease-specific PARASOL projects for FSGS, membranous, APOL1, and beyond.

The episode also touches on Alport syndrome, where the ASCENT initiative is playing a similar endpoint-defining role, with roughly 45 companies interested.

Finally, Gillespie discusses practical trial challenges, including limited numbers of glomerular specialists, recruitment bottlenecks, and the need to mobilize community nephrologists. She highlights clinical trial boot camps that train new investigators and shows how collaborations with patient organizations (e.g., NEF Cure, IgAN Alliance) are critical for dissemination, pricing, and implementation once drugs are approved.

Neuen B, Wadhwani, S. Kidney Compass: The PARASOL Initiative, with Laura Mariani, MD, MS, and Daniel Gale, PhD, MB BChir. Hcplive.com. Published December 11, 2024. Accessed March 6, 2026. https://www.hcplive.com/view/kidney-compass-the-parasol-initiative-with-laura-mariani-md-ms-and-daniel-gale-phd-mb-bchir

Neuen B. Kidney Compass: PARASOL Findings and Implications for FSGS. HCPLive. Published 2024. Accessed March 6, 2026. https://www.hcplive.com/view/kidney-compass-parasol-findings-and-implications-for-fsgs

The PARASOL initiative is reshaping glomerular disease trials through shared data and improved surrogate endpoints.

PARASOL, Endpoints, and Rethinking Clinical Trials in Glomerular Disease

PLA2R, Membranous Nephropathy, and the PARASOL Membranous Project”

This episode builds a bridge from anti-nephrin autoantibodies to PLA2R-positive membranous nephropathy, positioning the latter as a role model for precision nephrology. 

Gillespie recalls work with NEF Cure around the years 2021 to 2023, when they evaluated ongoing membranous nephropathy trials to see how frequently anti-PLA2R antibodies were being measured. To their disappointment, several sponsors were not systematically collecting PLA2R data, a missed opportunity when the goal is to support surrogate endpoints beyond proteinuria.

Gillespie emphasizes how steroids are poorly tolerated, sharing her own short-term experience versus patients who endure months or years of therapy. She highlights that antibody dynamics can precede changes in proteinuria: if PLA2R (or other autoantibody) titers fall before proteinuria improves, this could justify earlier tapering of toxic therapies, rather than waiting 3 to 6 months for proteinuria to decline. This is the clinical promise of antibody-based endpoints.

Huber then situates PLA2R-positive membranous nephropathy in the broader history. It represents a rare full success story where the community:

Linked this to B cell–depleting therapies, such as rituximab, establishing precise, mechanism-based treatment.

Since commercial PLA2R assays have been available for over a decade, centers worldwide have accumulated large datasets, creating fertile ground for advanced analyses. This is the foundation for the PARASO membranous project under the International Society of Glomerular Disease (ISGD). The project’s aim is to refine proteinuria-based surrogate endpoints by integrating PLA2R antibody titers, measuring not only the effect on the symptom, proteinuria, but also on the molecular cause.

Huber describes alignment with regulators and stakeholders to pursue endpoint qualification that includes PLA2R dynamics. The project encompasses building global registries, aggregating and harmonizing existing datasets, and correlating antibody kinetics with outcomes. The ultimate goal is to create stronger, more predictive endpoints that will support better trial design, faster drug development, and improved decision-making in membranous nephropathy.

Neuen B, Wadhwani, S. Kidney Compass: The PARASOL Initiative, with Laura Mariani, MD, MS, and Daniel Gale, PhD, MB BChir. Hcplive.com. Published December 11, 2024. Accessed March 6, 2026. 

https://www.hcplive.com/view/kidney-compass-the-parasol-initiative-with-laura-mariani-md-ms-and-daniel-gale-phd-mb-bchir

Neuen B. Kidney Compass: PARASOL Findings and Implications for FSGS. HCPLive. Published 2024. Accessed March 6, 2026. 

https://www.hcplive.com/view/kidney-compass-parasol-findings-and-implications-for-fsgs

PLA2R antibodies are advancing precision care in membranous nephropathy and informing new surrogate endpoints through PARASOL.

PLA2R, Membranous Nephropathy, and the PARASOL Membranous Project

Anti-Nephrin Autoantibodies and Precision in Nephrotic Syndrome

In this episode, the spotlight shifts to anti-nephrin autoantibodies as a key example of deeper mechanistic understanding transforming care in minimal change disease and idiopathic nephrotic syndrome.

Huber begins by noting that the term “minimal change” belies the severity of these conditions. For example, patients can be profoundly nephrotic despite seemingly minor histologic changes, and many children historically carried the vague label “idiopathic nephrotic syndrome” because the underlying cause was unknown.

Over the last 2 years, evidence has accumulated that most of these cases are driven by autoantibodies, specifically anti-nephrin antibodies. Huber cites data suggesting that roughly 70% of adult minimal change disease and up to 90% of idiopathic nephrotic syndrome in children are associated with these antibodies. This reframes what was once idiopathic as a largely autoimmune, antibody-mediated disease.

Diagnostics: Anti-nephrin antibodies can serve as a diagnostic marker, helping to identify and categorize patients more precisely than broad histologic labels.

Prognosis and treatment response: Antibody levels may help predict outcomes and response to therapy, allowing clinicians to anticipate which patients will benefit from specific interventions.

Therapeutic targeting: Recognizing that disease is antibody-driven supports a shift from steroid-heavy regimens toward B cell–modifying or depleting therapies, aligning treatment with the underlying immunopathology.

Huber stresses that a key barrier today is the confinement of testing mainly to academic laboratories. To begin to impact daily nephrology practice, the field must develop standardized, commercially available, certified assays. He shares his center’s experience, where these antibodies are used to make diagnoses, guide treatment choices, monitor response, and even prepare for transplantation, for example, depleting antibodies in patients at high risk of recurrent FSGS post-transplant.

The episode underscores the potential for anti-nephrin testing to reduce reliance on steroids, improve timing of therapeutic changes, and move glomerular disease care further into the realm of precision medicine, provided access to robust assays becomes widespread.

Hillenbrand A. Adolescents, Young Adults With Glomerular Disease May Require Distinct Care. HCPLive. Published January 7, 2026. Accessed March 6, 2026. 

https://www.hcplive.com/view/young-adults-glomerular-disease-distinct-care

Kunzmann K. Glomerulonephritis Patients Face High Risk of Recurrence After Kidney Transplant. HCPLive. Published April 27, 2024. Accessed March 6, 2026. 

https://www.hcplive.com/view/glomerulonephritis-patients-high-risk-recurrence-kidney-transplant

Anti-nephrin autoantibodies are redefining minimal change disease and enabling more precise, steroid-sparing treatment strategies.

Anti-Nephrin Autoantibodies, Precision in Nephrotic Syndrome

APOL1 Kidney Disease: Community, Trust, and Trial Participation

This episode focuses on APOL1-mediated kidney disease (APOL1 KD) in amalgamation as a scientific and a social inflection point.

Gillepsie recounts her experience on the Kidney Health Initiative (KHI) board, where a steering committee and workgroup were formed around 2020–2021 to build a roadmap for answering the needs of APOL1 KD. As sponsors were developing therapies, the insufficiency of traditional trial paradigms for this disease became apparent.

APOL1 KD has a disproportionate impact on Black Americans and individuals of African ancestry, communities that have been historically underrepresented, marginalized, and justifiably distrustful of medical research. Gillepsie explains that running an APOL1 trial requires “extra things” beyond protocol design, most importantly, engaging patients where they are and in ways that respect their lived experience. In the US, this has shown up as partnering with churches and faith leaders.

From her experience, she shares a real-life example that illustrates how communication through trusted community members can transform participation in healthcare settings. 

In a church with 103 congregants, after a preacher described a clinical trial for H. pylori reflux, 95 people consented to be screened.

APOL1 KD has therefore become a model for multi-stakeholder engagement, involving patients, faith leaders, clinicians, and sponsors.

Gillepsie outlines the 3 main objectives of the KHI APOL1 project:

Raise awareness of kidney disease and its disproportionate impact on Black Americans, including APOL1.

Increase screening for APOL1 variants and associated kidney disease.

Boost clinical trial participation so potential therapies can be robustly tested and reach patients.

She notes the extraordinary speed of progress for this disease. In 2011, high-risk variants APOL1 were discovered, and within about 15 years, phase 2 and 3 development programs are underway.

She contrasts this with IgA nephropathy (IgAN), first described in 1968, where it took > 50 years to get the first drug approved, and focal segmental glomerulosclerosis, first described a century ago, where appropriate endpoints are only now emerging.

APOL1 KD exemplifies how genotype-directed therapy plus thoughtful community engagement can compress timelines and bring precision medicine into nephrology.

Janeczko LL. Acute Kidney Failure Is More Prevalent Among African-Americans. HCPLive. Published November 8, 2013. Accessed March 6, 2026. 

https://www.hcplive.com/view/acute-kidney-failure-is-more-prevalent-among-african-americans

Campbell P. Inaxaplin Shows Promise for APOL1-Mediated FSGS in Phase 2a Trial. HCPLive. Published March 17, 2023. Accessed March 6, 2026. 

https://www.hcplive.com/view/inaxaplin-shows-promise-for-apol1-mediated-fsgs-in-phase-2a-trial

APOL1 kidney disease highlights the need for community trust, increased screening, and stronger clinical trial participation.

Rapid advances in glomerular disease, from single-cell tech to biomarkers and phase 3 trials, are reshaping diagnosis and treatment.

ISGD and the Fastest 5 Years in Glomerular Disease

Phase 2 ALPHA-SOLAR data presented at AAAAI 2026 show navenibart provides >95% median attack reduction in HAE with favorable safety for 3- and 6-month prophylaxis.


Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

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.

Navenibart at 3- and 6-Month Dosing Reduces HAE Attacks, With Adil Adatia, MD

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Articles

This FDA News Month in Review provides a round-up of regulatory decisions from February 2026.

FDA News

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

6 FDA Headlines You Missed in February 2026

This Q&A with Neal Bhatia, MD, features a discussion conducted regarding GLP-1 use in patients with psoriasis and obesity or overweight.

Plaque Psoriasis

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

Q&A on Treating Psoriasis, Obesity with Tirzepatide and Ixekizumab, With Neal Bhatia, MD

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.

In this segment of Liver Lineup, experts discuss the complexity of hepatitis B guidelines and why it’s important to empower clinicians and expand care beyond specialists.

Hepatology

Hepatitis C

Hepatitis C page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis C virus research, treatment, and drug development.

Are We Making Hepatitis B Treatment Too Complicated?

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. 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.

This month in review features 7 allergy headlines in February 2026: FDA's decision on Dupilumab for AFRS, late-breaking data presented at AAAAI, & more.

Anaphylaxis

The HCPLive anaphylaxis page is a comprehensive resource for clinical news and insights on acute allergic reactions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for preventing anaphylaxis, and more.

7 Allergy Headlines You Missed in February 2026

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Diabetes Dialogue cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss topline results from the TRIUMPH-4 trial, demonstrating retatrutide's efficacy in promoting weight loss.

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.

Diabetes Dialogue

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a monthly podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

TRIUMPH-4: Topline Data Highlights Retatrutide's Significant Weight Loss Effects

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.

Twice-daily delgocitinib cream 20 mg/g in those with moderate to severe chronic hand eczema led to significant HRQoL improvements.

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.

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.

DELTA: Delgocitinib Cream Improves Health-Related Quality of Life in CHE

Professor of Immunology and Allergy at Imperial College London and 
European Academy of Allergy and Clinical Immunology (EAACI) Secretary General

Shamji discussed the advantages of PQ grass over conventional immunotherapy at AAAAI 2026.

PQ Grass: Convenient Symptom Relief in Seasonal Allergic Rhinitis, With Mohamed Shamji, PhD

Douglas P. Mack, a pediatric allergist and assistant clinical professor at McMaster University

A randomized crossover study shows that most patients prefer intranasal epinephrine for anaphylaxis due to its ease of use, portability, and the absence of needles.

Latest News

Clinical Trial Summit 2026: Advanced Therapies, Equity, Global Outlook For Glomerular Diseases

PARASOL, Endpoints, and Rethinking Clinical Trials in Glomerular Disease

PLA2R, Membranous Nephropathy, and the PARASOL Membranous Project

Anti-Nephrin Autoantibodies, Precision in Nephrotic Syndrome

APOL1 Kidney Disease: Community, Trust, and Trial Participation