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

ClinicalTrials.gov ID: NCT05156710

Public ClinicalTrials.gov record NCT05156710. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 8, 2026, 10:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT05156710
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Sanofi; Industry
Enrollment: 48 participants

Conditions and interventions

Conditions

Transplant Rejection

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 8, 2022
Primary completion: Oct 20, 2025
Completion: Oct 19, 2026
Last update posted: Aug 20, 2026

2022 – 2026

United States locations

U.S. sites: 7
U.S. states: 4
U.S. cities: 5

Facility	City	State	ZIP	Site status
Cedars-Sinai Medical Center- Site Number : 8400100	Los Angeles	California	90048	—
University of California Los Angeles Medical Center- Site Number : 8400103	Los Angeles	California	90095	—
University of California San Francisco - Parnassus Heights- Site Number : 8400001	San Francisco	California	94143	—
Massachusetts General Hospital- Site Number : 8400007	Boston	Massachusetts	02114	—
Brigham & Women's Hospital- Site Number : 8400004	Boston	Massachusetts	02115	—
NYU Langone Medical Center- Site Number : 8400102	New York	New York	10016	—
University of Wisconsin Hospitals and Clinics- Site Number : 8400003	Madison	Wisconsin	53792	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05156710, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 20, 2026 · Synced Sep 8, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05156710 live on ClinicalTrials.gov.

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