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NCT05156710 · ClinicalTrials.gov registry record · Phase 2
BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
A Phase 2 study of Transplant Rejection, sponsored by Sanofi.
- Active
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 20
- Study locations
NCT05156710 is a Phase 2 study of Transplant Rejection that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 48 participants. The trial reports 20 study locations across 10 states.
The verdict
NCT05156710, a Phase 2 study of Transplant Rejection, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Conditions Studied
Interventions
- DRUG Tacrolimus
- DRUG Antithymocyte globulin (ATG)
- DRUG BIVV020 (SAR445088)
- DRUG Intravenous immunoglobulin (IVIg)
- DRUG Rituximab or biosimilar
Study Locations (20)
Other
- 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
California
- Cedars-Sinai Medical Center- Site Number : 8400100 - Los Angeles
- University of California Los Angeles Medical Center- Site Number : 8400103 - Los Angeles
- University of California San Francisco - Parnassus Heights- Site Number : 8400001 - San Francisco
Massachusetts
- Massachusetts General Hospital- Site Number : 8400007 - Boston
- Brigham & Women's Hospital- Site Number : 8400004 - Boston
British Columbia
- Investigational Site Number : 1240101 - Vancouver
- Investigational Site Number : 1240001 - Vancouver
New York
- NYU Langone Medical Center- Site Number : 8400102 - New York
Wisconsin
- University of Wisconsin Hospitals and Clinics- Site Number : 8400003 - Madison
Ontario
- Investigational Site Number : 1240002 - London
Quebec
- Investigational Site Number : 1240003 - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-06-09 |
| Est. Completion | 2026-10-26 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05156710
The ClinicalTrials.gov registry entry for NCT05156710 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Transplant Rejection appearing as the primary indexed condition, and to 5 interventions - of which Tacrolimus is the first listed.
NCT05156710 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05156710 about?
NCT05156710 is a clinical study titled "BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)". 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 ...
What is the current status of trial NCT05156710?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2022-06-09. Estimated completion is 2026-10-26.
What conditions does trial NCT05156710 study?
This clinical trial studies the following conditions: Transplant Rejection.
What interventions are being tested in trial NCT05156710?
The interventions under investigation include: Tacrolimus (DRUG), Antithymocyte globulin (ATG) (DRUG), BIVV020 (SAR445088) (DRUG), Intravenous immunoglobulin (IVIg) (DRUG), Rituximab or biosimilar (DRUG).
Who is sponsoring clinical trial NCT05156710?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05156710 being conducted?
This trial has 20 study locations across California, Massachusetts, New York, Wisconsin, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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