BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)
NCT ID: NCT05156710
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2022-06-09
2026-10-26
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BIVV020 with Standard of Care (SOC) Cohort A
Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate.
BIVV020 (SAR445088)
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
BIVV020 with Standard of Care (SOC) Cohort B
Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab.
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
Corticosteroids
Pharmaceutical Form: Vary Route of Administration: Vary
Standard of Care (SOC) Cohort B
SOC includes plasmapheresis, IVIg, corticosteroids, rituximab.
Intravenous immunoglobulin (IVIg)
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Rituximab or biosimilar
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Corticosteroids
Pharmaceutical Form: Vary Route of Administration: Vary
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Cohort A: Participants with chronic kidney disease who will receive a kidney transplant from a living or deceased donor.
Cohort B: Participants who are kidney transplant recipients diagnosed with active AMR.
* BMI ≤ 40 kg/m2.
* Contraceptive use by women during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).
* Contraceptive use by men during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).
Exclusion Criteria
* Participants with known active ongoing infection as per below:
1. Positive HIV.
2. Positive HBV.
3. HCV with detectable HCV RNA.
4. 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Karpman D, Bekassy Z, Grunenwald A, Roumenina LT. A role for complement blockade in kidney transplantation. Cell Mol Immunol. 2022 Jul;19(7):755-757. doi: 10.1038/s41423-022-00854-5. Epub 2022 Mar 24. No abstract available.
Related Links
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ACT17012 kidney transplant - antibody-mediated rejection website
ACT17012 Plain Language Results Summary
Other Identifiers
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U1111-1267-2612
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-509936-25-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-509936-25
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-000010-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACT17012
Identifier Type: -
Identifier Source: org_study_id
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