What is the Purpose of this Study?
The purpose of the study is to evaluate whether an experimental medicine called BIVV020 can prevent antibody-mediated rejection (AMR) in patients with kidney transplants. BIVV020 is a type of antibody that binds to complement proteins. Complement proteins are part of the immune system, and in some diseases can cause destruction of cells in the body. AMR happens when harmful antibodies activate the complement proteins, leading to inflammation and damage to the kidney graft. Researchers will evaluate whether BIVV020 can prevent or stop activation of complement proteins that lead to AMR, when given in combination with standard-of-care treatment. The study will also examine how the body processes BIVV020, as well as how the immune system responds to treatment. BIVV020 will be given via intravenous (IV) infusion.
Eligibility
- -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.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
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.