Fortrea’s Dr. Barbara Gillespie co-authors pivotal paper rethinking membranous nephropathy trials in the anti-PLA2R era

Why this paper matters

The discovery of anti-PLA2R antibodies in 2009 has opened the door toward more personalized, biomarker-driven care for patients with Membranous Nephropathy.

In a new paper published in Kidney International, Fortrea’s Barbara Gillespie, MD, MMS, FASN, VP, Therapeutic Head of Nephrology and Adjunct Professor at the University of North Carolina, co-authors a call to action: it’s time to rethink how we design trials for primary membranous nephropathy (MN)—a leading cause of nephrotic syndrome in adults.

The paper, “Designing clinical trials for the treatment of membranous nephropathy in the anti-PLA2R era,” draws from a landmark scientific workshop hosted by NephCure Kidney International and supported by the FDA in January 2023. Dr. Gillespie joined leading voices from academia, industry, and regulatory agencies to explore how anti-PLA2R biomarkers can be more effectively integrated into MN drug development.

The insights shared during this session laid the groundwork to answer a critical question: how can we design smarter, faster, and more meaningful MN trials using anti-PLA2R?

“Research like this is critical because it brings us closer to more targeted treatments for patients and potentially improves our success rate towards meaningful advances in standards of care. At Fortrea, we’re committed to designing trials that reflect the latest science and deliver real-world impact—this publication is a step forward for both.”

— Andrew Hegedus, Chief Development Officer, Fortrea

What you need to know

• Anti-PLA2R could be a game-changer: It’s more than a diagnostic tool—in many patients, it’s a real-time window into disease activity. Antibody levels often drop before clinical symptoms improve, making it a powerful early signal of treatment response. This opens the door to earlier decision-making, potentially accelerating timelines and improving patient outcomes.
• But we need standardization: Assay variability and inconsistent thresholds are slowing progress. The paper calls for harmonized testing and shared definitions of remission. Without alignment across platforms and studies, it’s difficult to compare results or establish anti-PLA2R as a validated surrogate endpoint—something regulators and sponsors alike are eager to see.
• Patients are ready: They want faster answers, better access to trials, and a voice in the process. This paper puts their perspectives front and center. Patients emphasized the need for clearer communication, more inclusive trial designs, and a stronger role in shaping research priorities—insights that can help sponsors build more patient-centric programs.
• The future is integrated: Combining anti-PLA2R with traditional markers like proteinuria could unlock more adaptive, efficient trial designs. This dual approach allows for a more nuanced understanding of disease progression and treatment response, enabling smarter stratification and more targeted interventions.

Read the full article in Kidney International 

Fortrea is here to help

Designing effective trials in membranous nephropathy takes more than clinical expertise. It requires deep knowledge of evolving regulatory expectations, validated endpoints, and the latest biomarker science.

At Fortrea, our nephrology team brings vast experience in kidney research and global trial execution—plus a seat at the table shaping the future of the field.

“The workshop concluded with a strong consensus: we need to bring together existing membranous nephropathy datasets, registries, and biorepositories—from academia and pharma, including aPLA2R data from clinical trials—to address these challenges collaboratively. The KHI (Kidney Health Initiative) project that supported proteinuria reduction as a surrogate EP for IgAN clinical trials has led to several drug approvals and counting. This model of analyzing pooled data that is shared is also showing promise in FSGS through the recent success of the PARASOL project. Defining successful regulatory paths for new drugs across the glomerular diseases is critical for improving our patients’ health and lives.”

— Barbara Gillespie, MD, MMS, FASN

Whether you're refining your protocol, selecting endpoints, or planning global execution, we’re ready to collaborate and guide you every step of the way.

Reach out to us today and let’s talk about how Fortrea can support your next breakthrough.

Learn more about our nephrology offering.

References

Prunotto M, Nachman PH, Gillespie BS, et al. Designing clinical trials for the treatment of membranous nephropathy in the anti-PLA2R era: results of a NephCure membranous nephropathy workshop. Kidney Int. 2025 May;107(5):809–815.