Kidney Week

Abstract: INFO17-FR

PROMINENT: An Open-Label, Randomized Phase 3 Trial of Felzartamab in Primary Membranous Nephropathy

Session Information

• Informational Posters - 2
  November 07, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• No subcategory defined

Authors

• Floege, Jürgen, Division of Nephrology and Cardiology, RWTH Aachen University, Aachen, Germany

Jürgen Floege, MD

• Ronco, Pierre M., Sorbonne Université & Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche, Paris, France

Pierre M. Ronco, MD, PhD

• Liew, Adrian, The Kidney & Transplant Practice, Mount Elizabeth Novena Hospital, Singapore, Singapore

Adrian Liew, MD, MBBS, FASN

• Reich, Heather N., Department of Medicine, Division of Nephrology, University Health Network, University of Toronto, Toronto, Ontario, Canada

Heather N. Reich, MD, PhD

• Jha, Vivekanand, George Institute for Global Health, UNSW, New Delhi, India

Vivekanand Jha, MD

• Shah, Millie, Biogen, South San Francisco, California, United States

Millie Shah, PhD

• Kivman, Lisa, Biogen, South San Francisco, California, United States

Lisa Kivman

• Chinn, Leslie W., Biogen, South San Francisco, California, United States

Leslie W. Chinn

• Tan, Yingmeei, Biogen, South San Francisco, California, United States

Yingmeei Tan, PhD

• Beckett, Valeria, Biogen, South San Francisco, California, United States

Valeria Beckett

• Chang, Ingrid J., Biogen, South San Francisco, California, United States

Ingrid J. Chang, MD, MBA

• Patel, Uptal D., Biogen, South San Francisco, California, United States

Uptal D. Patel, MD

• Rovin, Brad, Division of Nephrology, The Ohio State University, Columbus, Ohio, United States

Brad Rovin, FASN

Description

Primary membranous nephropathy (PMN) is a rare autoimmune kidney disease in which pathogenic autoantibodies bind to podocyte antigens, resulting in the in-situ formation of subepithelial immune complexes and complement-mediated podocyte injury with damage to the glomerular filtration barrier leading to severe proteinuria and progressive decline in estimated glomerular filtration rate (eGFR) in a subset of patients. Felzartamab, a monoclonal antibody directed against CD38, selectively targets CD38⁺ plasma cells and plasmablasts that produce pathogenic autoantibodies (eg, anti-phospholipase A2 receptor [PLA2R] autoantibodies). In Phase 2 studies, felzartamab reduced anti-PLA2R titers, improved proteinuria and serum albumin levels, and stabilized eGFR.

PROMINENT (NCT06962800) is an open-label, multicenter, randomized Phase 3 study in which 180 adults with newly diagnosed or relapsed biopsy-confirmed PMN in need of immunosuppressive therapy will be randomized to IV felzartamab or oral tacrolimus in protocol-specified dosing regimens. Both anti-PLA2R positive and negative participants are eligible; anti-PLA2R positive participants may be eligible without a biopsy. Participants must be on a stable, optimized dose of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, have an eGFR ≥30 mL/min/1.73 m², and a 24-hr urine protein-creatinine ratio of ≥3.0 g/g or total proteinuria ≥3.5 g/day after optimized supportive care for ≥3 months. The primary endpoint is the percentage of participants achieving complete clinical remission at 104 wks. Participants who experience worsening kidney function or proteinuria, relapse, or do not improve on assigned treatment can receive rescue treatment.

PROMINENT is the first Phase 3 trial evaluating the targeting of CD38⁺ plasma cells and plasmablasts in PMN to reduce proteinuria and preserve kidney function, which may address an unmet need in a disease with no approved therapies.

Funding

• This study was sponsored by Biogen.