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.

Barbara Gillespie, MD

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. 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.

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. Gillespie underscores the importance of this shift, echoing other leading voices in the field 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 ASSENT 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 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 PARASOL 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.

Barbara Gillespie, MD

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