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BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
Sponsor: Sanofi
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
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2022-06-09
Completion Date
2026-10-26
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
BIVV020 (SAR445088)
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Intravenous immunoglobulin (IVIg)
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Rituximab or biosimilar
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Antithymocyte globulin (ATG)
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Tacrolimus
Pharmaceutical Form: Tablet Route of Administration: Oral
Mycophenolate
Pharmaceutical Form: Tablet Route of Administration: Oral
Corticosteroids
Pharmaceutical Form: Vary Route of Administration: Vary
Locations (27)
Cedars-Sinai Medical Center- Site Number : 8400100
Los Angeles, California, United States
University of California Los Angeles Medical Center- Site Number : 8400103
Los Angeles, California, United States
University of California San Francisco - Parnassus Heights- Site Number : 8400001
San Francisco, California, United States
Massachusetts General Hospital- Site Number : 8400007
Boston, Massachusetts, United States
Brigham & Women's Hospital- Site Number : 8400004
Boston, Massachusetts, United States
NYU Langone Medical Center- Site Number : 8400102
New York, New York, United States
University of Wisconsin Hospitals and Clinics- Site Number : 8400003
Madison, Wisconsin, United States
Investigational Site Number : 1240101
Vancouver, British Columbia, Canada
Investigational Site Number : 1240001
Vancouver, British Columbia, Canada
Investigational Site Number : 1240002
London, Ontario, Canada
Investigational Site Number : 1240003
Montreal, Quebec, Canada
Investigational Site Number : 2500007
Bordeaux, France
Investigational Site Number : 2500002
Créteil, France
Investigational Site Number : 2500001
Paris, France
Investigational Site Number : 2500005
Toulouse, France
Investigational Site Number : 2760002
Berlin, Germany
Investigational Site Number : 2760004
Essen, Germany
Investigational Site Number : 2760001
Munich, Germany
Investigational Site Number : 3800004
Bologna, Emilia-Romagna, Italy
Investigational Site Number : 3800002
Rome, Lazio, Italy
Investigational Site Number : 3800001
Brescia, Lombardy, Italy
Investigational Site Number : 3800003
Milan, Milano, Italy
Investigational Site Number : 7240004
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240003
Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7240002
Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7520001
Huddinge, Sweden
Investigational Site Number : 7520002
Uppsala, Sweden