BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
Active, not recruiting · Phase 2 · NCT05156710
Conditions: Transplant Rejection
At a glance
- Research payments reported, 2025
- $629,747
- U.S. investigators named
- 7
- Sites paid
- 7
- Planned or actual enrollment
- 48
About the trial
- Sponsor
- Sanofi
- Tested
- BIVV020 (SAR445088) (drug), Intravenous immunoglobulin (IVIg) (drug), Rituximab or biosimilar (drug), Antithymocyte globulin (ATG) (drug), Tacrolimus (drug), Mycophenolate (drug), Corticosteroids (drug)
- Dates
- Started 2022-06-09; completion 2026-10-20
- Results posted
- Not yet
Primary Objectives: * Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR * Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR Secondary Objectives: * To assess the overall efficacy of BIVV020 in prevention or treatment of AMR * To characterize the safety and tolerability of BIVV020 in kidney transplant participants * To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants * To evaluate the immunogenicity of BIVV020
From ClinicalTrials.gov, last updated 2026-08-21. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $629,747 in research payments for this study in 2025 (30 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Amarpali Brar, M.D Nephrology (Kidney) · San Francisco, CA
- Suphamai Bunnapradist, M.D. Nephrology (Kidney) · Los Angeles, CA
- Stanley Jordan, MD Nephrology (Kidney) · West Hollywood, CA
- Anil K. Chandraker, MBCHB Nephrology (Kidney) · Worcester, MA
- Leonardo V. Riella, M.D., PHD Internal Medicine · Boston, MA
- Arjang Djamali, MD General Practice · Portland, ME
- Irfana H. Soomro, M.D Nephrology (Kidney) · New York, NY
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Ronald Reagan UCLA Medical Center, CA $458,837
- Cedarssinai Medical Center $68,265
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $63,061
- New York University NYU Grossman School of Medicine An Administrative Unit of New York University $13,051
- Board of Regents of the University of Wisconsin System $12,590
- Massachusetts General Hospital Attn Research Finance Attn 2021a $9,343
- Brigham and Women's Hospital, MA $4,600
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.