Felzartamab in Kidney Txp with AMR - TRANSCEND (Post-Transplant Kidney Rejection)

Purpose of this Study

We are doing this study to find out if an experimental drug called felzartamab (the study drug) is a safe and effective option for people who have had a kidney transplant and are experiencing antibody-mediated rejection (AMR). We want to know if this drug provides any helpful benefit.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with active or chronic AMR of a donor kidney
  • Are up-to-date on all recommended vaccines
  • Are on stable immunosupression therapy consistent with clinical guidelines
For more information, contact the study team at jerry.turner@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

There are two parts to this study, Part A and Part B. Whether you participate in Part A or Part B will depend on when you join the study. We will let you know which part of the study is active before you make a decision to join. If you choose to join this study during Part A, you will get a random assignment (like a coin flip) to 1 of 2 groups:
  • Group 1: If you are in this group, you will get the study drug.
  • Group 2: If you are in this group, you will get a placebo (inactive substance with no drug in it).
During Part B of the study, all participants will get the study drug. The study drug or placebo is administered by intravenous (IV) infusion into a vein in the arm. During the course of the study, all participants will have physical exams, blood draws, biopsies, and surveys to fill out.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

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 (AMR) (TRANSCEND)

Principal Investigator

Scott
Sanoff

Protocol Number

PRO00116881

NCT ID

NCT06685757

Phase

III

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov