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A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)
120 patients around the world
Available in Brazil, United States
The primary objective of this study is to evaluate the efficacy of felzartamab compared
to placebo in kidney transplant recipients diagnosed with active or chronic active AMR.
The secondary objectives of this study are: Part A: To evaluate the efficacy of
felzartamab compared to placebo through additional clinical endpoints; Part B: To
summarize felzartamab efficacy at Week 52 in kidney transplant recipients diagnosed with
active or chronic active AMR; Parts A and B: To evaluate the safety of felzartamab in
kidney transplant recipients diagnosed with active or chronic AMR and to assess the
pharmacokinetic (PK) profile and immunogenicity of felzartamab.
Biogen
1Research sites
120Patients around the world
This study is for people with
Kidney Transplant
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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.Other protocol-defined inclusion/exclusion criteria apply.
- Transplant: Blood type (ABO)-incompatible transplant.History of multiple organ transplants including en bloc and dual kidney transplants.Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the subsequent 30 days as determined by the Investigator.Treatment: Prior AMR/TCMR treatment (with the exception of corticosteroids) within 3 months prior to randomization is excluded as listed below.Participants who received any of these treatments between 3 and 6 months prior to randomization must have both a renal biopsy (IC3) and DSA testing at least 6 weeks after completing (or stopping) treatment in order to confirm continuing AMR and to determine eligibility.Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin [SCIg]) or PLEX.Complement system inhibitors (e.g., eculizumab).Proteasome inhibitors (e.g., bortezomib).Tocilizumab.Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization.
Sites
Hospital do Rim - HRIM– Fundação Oswaldo Ramos
Recruiting
StudyTRANSCEND
SponsorBiogen
Study typeInterventional
Conditions
Kidney Transplant
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06685757
