What is the Purpose of this Study?
Primary Objective (Part A): To evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with active or chronic active AMR. Secondary Objective (Part A): To evaluate the efficacy of felzartamab compared to placebo through additional clinical endpoints. Secondary Objective (Part B Arm 1): To summarize felzartamab efficacy at Week 52 in kidney transplant recipients diagnosed with active or chronic active AMR who were randomized to active drug at Baseline and continued to receive felzartamab Secondary Objective (Part B Arm 2): To summarize felzartamab efficacy at Week 52 in kidney transplant recipients diagnosed with active or chronic active AMR who were randomized to placebo and initiated felzartamab at Week 24 in Part B Secondary Objective (Parts A and B): To evaluate the safety of felzartamab in kidney transplant recipients diagnosed with active or chronic AMR; To assess the PK profile and immunogenicity of felzartamab
Eligibility
- * Active or chronic active AMR (biopsy-confirmed) without TCMR per central reading, as defined by the Banff 2022 criteria.
- * Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors).
- * Donor-specific antibody (DSA): Human leukocyte antigen (HLA) Class I and/or II antigen-specific DSA-positive (preformed and/or de novo DSA) as determined by the local laboratory's definition of positivity using singleantigen bead-based assays within 3 months prior to randomization.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients with Late Antibody-Mediated Rejection