Actively Recruiting
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)
Led by argenx · Updated on 2026-03-18
30
Participants Needed
23
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation. After a screening period of up to 6 weeks, eligible participants will be randomized in a 1:1:1 ratio. The study drug will be administered subcutaneously while patients remain on their standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, steroids) during the treatment period (48 weeks). At the end of the treatment period, the participants will enter an observational/follow-up period (approximately 24 weeks). The participants will be in the study for up to 78 weeks.
CONDITIONS
Official 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...
- Ages 18 to 80 years
- Had a kidney transplant (living or deceased donor) at least 6 months before the study
- Diagnosed with active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at study entry
- Received mycophenolate mofetil for at least 20 weeks before the study
- On a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before study start
- Tacrolimus dose maintained between 5 to 10 ng/mL for at least 4 weeks before study entry
- Steroid dose between 0 to 10 mg per day of prednisone or equivalent for at least 4 weeks before study entry
You will not qualify if you...
- Confirmed T-cell or mixed rejection at the time of the study
- Recent changes in immunosuppressive therapy
- Any medical condition that could interfere with the study results or increase risk according to the investigator
- Pregnant or breastfeeding, or planning to become pregnant during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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