BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)
Study on an Investigational Medication for 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: 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.
This study investigates the use of an investigational medication in people who have received or will receive a kidney transplant. Kidney transplantation is a procedure where a healthy kidney from a donor is placed into a person whose kidneys are not working properly. The study focuses on two groups, or arms. The first arm includes people who are at risk of developing antibody-mediated rejection (AMR) after receiving a transplant. The second arm includes people who already have active AMR, which is a condition where the immune system attacks the new kidney.
Participants will receive either the investigational medication or standard of care treatment. The study will evaluate how well the investigational medication works in preventing or treating AMR in these participants. The study will also look at the safety of the investigational medication and how it is processed in the body. Additionally, researchers will study the body's immune response to the medication.
- Who can participate: Adults with chronic kidney disease receiving a kidney transplant or diagnosed with active antibody-mediated rejection can participate. Participants must have a BMI of 40 or less and agree to use contraception.
- Study details: Participants will be assigned to receive either the investigational medication or the standard of care treatment. The study will monitor how the investigational medication affects the body and its safety in kidney transplant patients. A placebo will not be used in this study.
- Study Timelines: The study will last up to approximately 2 years.