Kidney Week

Abstract: INFO17-TH

TRANSCEND: A Phase 3 Trial of the Anti-CD38 Antibody Felzartamab in Kidney Transplant Recipients with Late Antibody-Mediated Rejection

Session Information

• Informational Posters - 1
  November 06, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Transplantation

• No subcategory defined

Authors

• Bohmig, Georg, Medical University of Vienna, Vienna, Austria

Georg Bohmig, MD

• Budde, Klemens, Charité Universitätsmedizin Berlin, Berlin, Germany

Klemens Budde, MD

• Cibrik, Diane Marie, University of Kansas Medical Center, Kansas City, Kansas, United States

Diane Marie Cibrik, MD

• Schinstock, Carrie A., Mayo Clinic, Rochester, Minnesota, United States

Carrie A. Schinstock, MD

• Mengel, Michael, University of Alberta, Edmonton, Alberta, Canada

Michael Mengel, MD

• Reed, Elaine F., University of California, Los Angeles, California, United States

Elaine F. Reed, PhD

• Ingle, Gordon R., Biogen, South San Francisco, California, United States

Gordon R. Ingle

• Flesher, Donna, Biogen, South San Francisco, California, United States

Donna Flesher, PhD

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

Leslie W. Chinn

• Holt, Curtis D., Biogen, South San Francisco, California, United States

Curtis D. Holt

• Manser, Paul, Biogen, South San Francisco, California, United States

Paul Manser

• Micsa, Lenuta, Biogen, South San Francisco, California, United States

Lenuta Micsa

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

Uptal D. Patel, MD

• Mannon, Roslyn B., University of Nebraska Medical Center, Omaha, Nebraska, United States

Roslyn B. Mannon, MD, FASN

Description

Antibody-mediated rejection (AMR) is a major cause of kidney allograft failure. Felzartamab, a fully human IgG1 monoclonal antibody targeting CD38, may deplete donor-specific antibody (DSA)–producing plasma cells, along with natural killer (NK) cells, potentially reducing AMR-associated microvascular inflammation (MVI) and graft injury. This study evaluates the efficacy and safety of felzartamab in kidney transplant recipients with late active or chronic active AMR.

TRANSCEND (NCT06685757) is a double-blind, placebo-controlled, multicenter, randomized Phase 3 trial. Approximately 120 participants with late (≥6 months) active or chronic active AMR post-kidney transplant will be randomized to receive felzartamab or placebo. Key inclusion criteria were active or chronic active AMR (biopsy confirmed) per Banff 2022 criteria, kidney transplant ≥6 months prior to screening, and presence of HLA-DSA. This 52-week study consists of Part A (24 weeks, placebo controlled) and Part B (28 weeks, open-label felzartamab). In Part A, participants receive either IV felzartamab or placebo. In Part B, all participants receive IV felzartamab. Kidney allograft biopsies will be performed at baseline, Week 24, and Week 52. The primary endpoint is the percentage of participants who achieve biopsy-proven histologic resolution at Week 24. Key secondary endpoints include changes in MVI score, levels of donor-derived cell-free DNA, biopsy-based transcript scores, and change in estimated glomerular filtration rate, as well as safety. The trial began enrolling participants in Q1 2025. Results will be reported at a later date, after all patients have completed 6 months of follow-up.

TRANSCEND is the first Phase 3 trial evaluating the concept of CD38 targeting in AMR after kidney transplant. Results from this study may provide a novel treatment option and potentially transformative therapy for this challenging condition of high unmet medical need.