A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)

Purpose

The main goal of this trial is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with late active or chronic active AMR.

Condition

  • Antibody-mediated Rejection

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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: 1. Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin [SCIg]) or PLEX. 2. Complement system inhibitors (e.g., eculizumab). 3. Proteasome inhibitors (e.g., bortezomib). 4. Tocilizumab. e. Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization. Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
This is a 2-part trial; Part A will be randomized and placebo-controlled, and Part B will be open-label.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Felzartamab
  • Drug: Felzartamab
    Participants will receive felzartamab by intravenous infusion.
    Other names:
    • MOR202
    • MOR03087
    • TJ202
    • HIB202
    • BIIB148
Placebo Comparator
Placebo
  • Drug: Placebo
    Participants will receive 0.9% saline solution by intravenous infusion.

Recruiting Locations

University of Kansas
Kansas City, Kansas 66160
Contact:
913-588-8239

More Details

Status
Recruiting
Sponsor
Biogen

Study Contact

US Biogen Clinical Trial Center
1-866-633-4636
clinicaltrials@biogen.com

Detailed Description

NOTE: Biogen is the Sponsor of study 299AR301.