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BIVV020 (SAR445088) in prevention and treatment of antibody-mediated rejection (AMR)
EU CTIS ID: 2023-509936-25-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
- 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).
You likely can't join if
- Participants who are ABO incompatible with their donors.
- Participants with known active ongoing infection as per below: a) Positive HIV. b) Positive HBV. c) HCV with detectable HCV RNA. d) Within 4 weeks of first study intervention: any serious infection, or any active bacterial infection i, 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 study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.