BIVV020 in Prevention and Treatment of Antibody-mediated Rejection (AMR)

Investigating the Use of an Investigational Medication for Kidney Transplant Patients

Recruiting
18 years - 75 years
All
Phase 2
54 participants needed
2 Locations

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
  • Age: 18 years - 75 years
  • 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 to whom they are sensitized, and/or required
        desensitization prior to transplantation.
        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).
          -  18-75 years old at the time of consent.
        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 infection
                  requiring antibiotic treatment against an identified or suspected bacterial
                  pathogen.
          -  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.

Updated on 16 Jan 2025. Study ID: NCT05156710

This study investigates the use of an investigational medication in patients who have undergone or will undergo a kidney transplant. The study focuses on a condition called antibody-mediated rejection (AMR), which can occur after a kidney transplant. AMR happens when the body's immune system attacks the new kidney. The study has two main parts, or arms: one for preventing AMR and another for treating active AMR.

Participants in this study will receive either the investigational medication or standard care. Those in the investigational medication group may receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will also monitor the safety and how the body processes the investigational medication in kidney transplant patients.

  • Who can participate: Adults aged 18 to 75 who are either planning to receive a kidney transplant or have already received one can participate. Key eligibility includes a BMI of 40 or less and the use of contraceptives during and after treatment. Participants in Cohort A need to be sensitized to their donor and/or require desensitization. Participants must not have certain infections or incompatible donors.
  • Study details: Participants will be assigned to either receive the investigational medication or standard care. Some participants may receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.
  • Study Timelines: The study will last up to approximately 2 years.

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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