Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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

Official Title

A Multi-cohort, Randomized, Phase 2, Open-label Study to Assess the Preliminary Efficacy, Safety, and Pharmacokinetics of BIVV020 for Prevention and Treatment of Antibody-mediated Rejection in Adult Kidney Transplant Recipients.

Details

Up to approximately 2 years

Keywords

Transplant Rejection, Rituximab, Tacrolimus, Immunoglobulins, Intravenous Immunoglobulins, Antibodies, Antilymphocyte Serum, gamma-Globulins, Rho(D) Immune Globulin, BIVV020 (SAR445088), Intravenous immunoglobulin (IVIg), Rituximab or biosimilar, Antithymocyte globulin (ATG), Mycophenolate, Corticosteroids

Eligibility

You can join if…

Open to people ages 18 years and up

-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).

You CAN'T join if...

  • 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.

Locations

  • UCSF Site Number : 8400001 accepting new patients
    San Francisco California 94143 United States
  • Cedars-Sinai Medical Center Site Number : 8400100 accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
Links
ACT17012 kidney transplant - antibody-mediated rejection website
ID
NCT05156710
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 45 study participants
Last Updated