BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)
Study on an Investigational Treatment for Antibody-mediated Rejection in Kidney Transplant Patients
Study Overview
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 Details
Up to approximately 2 years
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Transplant Rejection
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
-Participant intended to receive SOC therapy per Investigator's judgment and local practice.
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 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.
This study investigates the use of an investigational medication in preventing and treating antibody-mediated rejection (AMR) in kidney transplant patients. The study involves two arms: Cohort A focuses on preventing AMR in patients receiving a kidney transplant, while Cohort B focuses on treating active AMR in patients who have already received a kidney transplant.
Participants will receive either the investigational medication or standard of care treatment. The study will evaluate the efficacy, safety, and tolerability of the investigational medication. Additionally, it will assess the pharmacokinetic profile, which is how the drug is absorbed, distributed, metabolized, and excreted in the body, as well as the immunogenicity, which is the ability of the drug to provoke an immune response.
- Who can participate: Adults with chronic kidney disease scheduled for a kidney transplant or those diagnosed with active AMR can participate. Participants must have a BMI of 40 kg/m2 or less and are excluded if they have certain infections or medical conditions, such as HIV, hepatitis, or systemic lupus erythematosus.
- Study details: Participants will be divided into two arms: one receiving the investigational medication and the other receiving standard of care. The study will monitor the safety and effectiveness of the treatments.
- Study timelines: The study will last approximately 2 years.
