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

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 US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) leaders and the approval of gene therapy for sickle cell disease.

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.2

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.

Featured Experts

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

Tobias Huber, MD, 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.

References

1. 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

2. 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