🏛️ Verified NIH Record • Updated 2026-08-17

BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR) (NCT05156710)

A Multi-cohort, Randomized, Phase 2, Open-label Study to Assess the Preliminary Efficacy, Safety, and Pharmacokinetics of BIVV020 for Prevention and Treatment of Antibody-mediated Rejection in Adult Kidney Transplant Recipients.

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Sanofi

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (11 items).

Location: Cedars-Sinai Medical Center- Site Number : 8400100 — Los Angeles, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Participants who are ABO incompatible with their donors.
  • Participants with known active ongoing infection as per below:
  • Positive HIV.
  • Positive HBV.
  • HCV with detectable HCV RNA.
  • Within 4 weeks of first study intervention: any serious infection, or any active bacterial infection, or any other infection which is clinically significant in the option of the Investigator, unless it can be confirmed that infection was cleared at least 3 days prior to first study intervention.
  • History of active tuberculosis (TB) regardless of treatment.
  • Participants with clinical diagnosis of systemic lupus erythematosus (SLE).
  • Prior treatment with complement system inhibitor within 5 times the half-life.
  • Current enrollment in any other clinical study where the last investigational study treatment administration was within 5 half-lives from study intervention initiation. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (27 Sites)

Showing the first 25 of 27 sites.

  • Cedars-Sinai Medical Center- Site Number : 8400100 — Los Angeles, California
  • University of California Los Angeles Medical Center- Site Number : 8400103 — Los Angeles, California
  • University of California San Francisco - Parnassus Heights- Site Number : 8400001 — San Francisco, California
  • Massachusetts General Hospital- Site Number : 8400007 — Boston, Massachusetts
  • Brigham & Women's Hospital- Site Number : 8400004 — Boston, Massachusetts
  • NYU Langone Medical Center- Site Number : 8400102 — New York, New York
  • University of Wisconsin Hospitals and Clinics- Site Number : 8400003 — Madison, Wisconsin
  • Investigational Site Number : 1240101 — Vancouver, British Columbia
  • Investigational Site Number : 1240001 — Vancouver, British Columbia
  • Investigational Site Number : 1240002 — London, Ontario
  • Investigational Site Number : 1240003 — Montreal, Quebec
  • Investigational Site Number : 2500007 — Bordeaux,
  • Investigational Site Number : 2500002 — Créteil,
  • Investigational Site Number : 2500001 — Paris,
  • Investigational Site Number : 2500005 — Toulouse,
  • Investigational Site Number : 2760002 — Berlin,
  • Investigational Site Number : 2760004 — Essen,
  • Investigational Site Number : 2760001 — Munich,
  • Investigational Site Number : 3800004 — Bologna, Emilia-Romagna
  • Investigational Site Number : 3800002 — Rome, Lazio
  • Investigational Site Number : 3800001 — Brescia, Lombardy
  • Investigational Site Number : 3800003 — Milan, Milano
  • Investigational Site Number : 7240004 — Barcelona, Barcelona [Barcelona]
  • Investigational Site Number : 7240003 — Madrid, Madrid, Comunidad de
  • Investigational Site Number : 7240002 — Madrid, Madrid, Comunidad de

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Transplant Rejection clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗