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NCT06685757 · ClinicalTrials.gov registry record · Phase 3

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)

A Phase 3 study of Antibody-mediated Rejection, sponsored by Biogen.

Recruiting
Registry status
Phase 3
Development phase
120
Enrollment target
20
Study locations

NCT06685757 is a Phase 3 study of Antibody-mediated Rejection that is actively recruiting participants, run by Biogen. The registered enrollment target is 120 participants, below the 148-participant average among 5 other Antibody-mediated Rejection trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT06685757, a Phase 3 study of Antibody-mediated Rejection, is actively recruiting participants, sponsored by Biogen.

RECRUITING
Registry status
Phase 3
Development phase
120 participants
Enrollment target
20
Study locations

Study Summary

In this study, researchers will learn more about the use of felzartamab in kidney transplant patients who have antibody-mediated rejection, also known as AMR. Kidney transplants can save lives for people with kidney failure. But even after a successful transplant, the body's immune system can sometimes attack the new kidney. Antibody-mediated rejection (AMR) is when a person's immune system attacks a transplanted organ, like a new kidney. In the person receiving the transplant, their immune system creates specific antibodies. Antibodies are proteins that help the body fight infections. In people with AMR, these antibodies mistakenly see the new organ as a threat and damage its blood vessels. This can cause the new organ to fail. In this study, researchers will learn more about how a study drug called felzartamab affects people with AMR. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce antibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works in participants with kidney transplants who experience AMR compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug. All participants in this study will have active AMR or AMR that has lasted for at least 6 months after their kidney transplant. The main question that researchers want to answer is: • How many participants have biopsy results showing that their transplanted kidney tissue looks normal or near normal after 24 weeks of treatment? Researchers will also learn about: * How long it takes before the participants' disease gets worse * How long the participants' urine protein levels stay low * Kidney biopsy scores to check for blood vessel inflammation at 6 months and 1 year * How many people have no blood vessel inflammation at these times * Changes in d

Conditions Studied

Antibody-mediated Rejection

Interventions

  • DRUG Placebo
  • DRUG Felzartamab

Study Locations (20)

California

  • University of Southern California - Los Angeles
  • Cedars-Sinai Medical Center - Los Angeles
  • UCLA - Los Angeles
  • Providence Healthcare - Orange
  • Loma Linda - San Bernardino
  • California Pacific Medical Center - San Francisco
  • University of California, San Francisco - San Francisco

Ohio

  • University of Cincinnati - Cincinnati
  • Cleveland Clinic - Cleveland
  • The Ohio State University - Columbus

Colorado

  • University of Colorado - Aurora

Illinois

  • University of Chicago - Chicago

Kansas

  • University of Kansas - Kansas City

Louisiana

  • Tulane University Health Sciences Center - New Orleans

Michigan

  • University of Michigan - Ann Arbor

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2024-12-03
Est. Completion 2027-06-01
Phase Phase 3

Sponsor

Biogen

334 total trials

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What the Registry Record Tells You About NCT06685757

The ClinicalTrials.gov registry entry for NCT06685757 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 148-participant average among 5 other Antibody-mediated Rejection trials with a reported enrollment target (19% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Antibody-mediated Rejection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06685757 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Ohio, Colorado.

Frequently Asked Questions

What is clinical trial NCT06685757 about?

NCT06685757 is a clinical study titled "A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)". In this study, researchers will learn more about the use of felzartamab in kidney transplant patients who have antibody-mediated rejection, also known as AMR. Kidney transplants can save lives for people with kidney failure. But even after a successful transplant, the body's immune system can someti...

What is the current status of trial NCT06685757?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2024-12-03. Estimated completion is 2027-06-01.

What conditions does trial NCT06685757 study?

This clinical trial studies the following conditions: Antibody-mediated Rejection.

What interventions are being tested in trial NCT06685757?

The interventions under investigation include: Placebo (DRUG), Felzartamab (DRUG).

Who is sponsoring clinical trial NCT06685757?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06685757 being conducted?

This trial has 20 study locations across California, Colorado, Illinois, Kansas, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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