Felzartamab in Kidney Transplant Recipients with Late Antibody-Mediated Rejection

What is the Purpose of this Study?

This study aims to learn more about the safety and effectiveness of an experimental drug called felzartamab in people who have received a kidney transplant and may have late antibody-mediated rejection (AMR). AMR is a type of transplant rejection in which the patient’s immune system produces antibodies that attack the transplanted organ. Study procedures include electrocardiograms, kidney biopsies, felzartamab and/or placebo (inactive substance) infusions, and laboratory assessments. Felzartamab is a monoclonal antibody, which is a type of laboratory-made substance designed to target cells that produce harmful donor-specific antibodies. Donor-specific antibodies are immune proteins that the body produces in response to a transplanted kidney, potentially leading to organ rejection. By targeting and eliminating these plasma cells, felzartamab helps reduce the risk of rejection and supports the success of the transplant. Researchers want to learn how well felzartamab works, as well as assess the drug’s pharmacokinetics (how the drug is processed through the body) and immunogenicity (how the drug works on the immune system).


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.
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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

Study Details
Disease Type/Condition

Other

Principal Investigator

Huang, Edmund

Co-Investigators

Alice Peng, Ashley Vo, Jun Shoji, Noriko Ammerman, Reiad Najjar, Sindhu Chandran, Stanley Jordan

Age Group

Adult

Phase

III

IRB Number

STUDY00003865

ClinicalTrials.gov ID

NCT06685757

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Huang, Edmund

Age Group

Adult

Phase

III

IRB Number

299AR301

ClinicalTrials.gov ID

NCT06685757

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org