Actively Recruiting
A Global, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 SC by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection
Led by argenx · Updated on 2026-03-18
30
Participants Needed
23
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of efgartigimod PH20 SC given by a prefilled syringe for people who have Antibody-Mediated Rejection (AMR) after a kidney transplant. This phase 2, randomized, double-blinded, placebo-controlled study aims to understand how this treatment works alongside standard immunosuppression therapy in this population. Participants will be randomly assigned to one of three groups: one receiving efgartigimod PH20 SC plus their usual immunosuppressive drugs, another receiving efgartigimod PH20 SC for 24 weeks followed by placebo for the next 24 weeks alongside immunosuppression, and a third group receiving placebo plus standard immunosuppression. The treatment period lasts 48 weeks, followed by an observational follow-up of about 24 weeks, totaling up to 78 weeks in the study. Throughout the study, participants will be monitored for side effects, treatment discontinuation, and changes in kidney function using blood tests, kidney biopsies, and urine tests. Researchers will also track drug levels and antibody responses. Participants will remain on their standard immunosuppression medications during treatment and will be followed regularly for up to 78 weeks to assess safety and kidney health.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Had a kidney transplant at least 6 months before the study
- Diagnosed with active or chronic active antibody-mediated rejection with detectable donor-specific antibodies
- Received mycophenolate mofetil for at least 20 weeks before the study
- On stable doses of mycophenolate mofetil and tacrolimus for at least 4 weeks before the study
- Tacrolimus dose between 5 to 10 ng/mL for at least 4 weeks before the study
- Steroid dose between 0 to 10 mg per day of prednisone or equivalent for at least 4 weeks before the study
You will not qualify if you...
- Confirmed T-cell or mixed rejection at time of the study
- Recent change in immunosuppressive therapy
- Medical conditions that could interfere with study results or pose undue risk
- Pregnant, breastfeeding, or planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive subcutaneous injections of either Efgartigimod PH20 SC or placebo by prefilled syringe along with optimized standard background immunosuppression therapy.
Regular visits during treatment period
Duration - Up to 30 weeks after treatment
Participants are monitored for safety, kidney function, and antibody levels after treatment ends.
Periodic visits after treatment completion
Trial Site Locations
Total: 23 locations
1
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
University of Chicago Medical Center
Chicago, Illinois, United States, 60615
Actively Recruiting
4
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
5
Duke University Hospital
Durham, North Carolina, United States, 27705
Actively Recruiting
6
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
7
Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center
Richmond, Virginia, United States, 23298
Actively Recruiting
8
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
9
Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus
Vienna, Austria, 1090
Actively Recruiting
10
Universitair Ziekenhuis (UZ) Gent
Ghent, Belgium, 9000
Actively Recruiting
11
Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
12
London Health Sciences Centre
London, Canada, N6A 5A5
Actively Recruiting
13
Institut klinicke a experimentalni mediciny (IKEM)
Prague, Czechia, 140-21
Actively Recruiting
14
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin
Bordeaux, France, 33076
Actively Recruiting
15
Centre Hospitalier Universitaire (CHU) de Grenoble Alpes - Hôpital Michallon
La Tronche, France, 38700
Actively Recruiting
16
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil
Toulouse, France, 31059
Actively Recruiting
17
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
18
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Actively Recruiting
19
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
20
Hospital Del Mar
Barcelona, Spain, 08003
Actively Recruiting
21
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
22
Hospital Universitario de Bellvitge
Barcelona, Spain, 08907
Actively Recruiting
23
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
Research Team
S
Sabine Coppieters, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here