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)
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Antibody-mediated Rejection
In brief
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.
Key facts
- Study ID
- NCT06503731
- Run by
- argenx
- People needed
- 33
- Starts
- 2024-08-30
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-07-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The participant is within the ages of 18 and 80 years old
- The participant had a kidney transplant (living or deceased donor) at least 6 months before the study
- The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of the study
- A participant may be allowed into the study if they receive the following medications:
- Received mycophenolate mofetil for at least 20 weeks before the study
- Has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study
- Has remained on tacrolimus doses between 5 to 10 ng/mL at least 4 weeks before being allowed to participate in the study
- Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for at least 4 weeks before being allowed to participate in the study
You may not qualify if…
- Confirmed T-cell or mixed rejection at time of the study
- Recent change in immunosuppressive therapy agents
- Any other medical condition that, in the investigator's opinion, would interfere with the results of the study or put the participant at undue risk
- Pregnant or lactating state or intention to become pregnant during the study
- The complete list of criteria can be found in the protocol
Where it is running
- University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- University of Chicago Medical Center — Chicago, Illinois, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Duke University Hospital — Durham, North Carolina, United States
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center — Richmond, Virginia, United States
- University of Washington Medical Center — Seattle, Washington, United States
- Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus — Vienna, Austria
- Universitair Ziekenhuis (UZ) Gent — Ghent, Belgium
- Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg — Leuven, Belgium
- London Health Sciences Centre — London, Canada
- Institut klinicke a experimentalni mediciny (IKEM) — Prague, Czechia
- Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin — Bordeaux, France
- Centre Hospitalier Universitaire (CHU) de Grenoble Alpes - Hôpital Michallon — La Tronche, France
- Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil — Toulouse, France
- Charité - Universitätsmedizin Berlin — Berlin, Germany
- Universitaetsklinikum Carl Gustav Carus Dresden — Dresden, Germany
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
- Hospital Del Mar — Barcelona, Spain
- Hospital Universitario Vall d'Hebron — Barcelona, Spain
- Hospital Universitario de Bellvitge — Barcelona, Spain
- Hospital Universitario Miguel Servet — Zaragoza, Spain
Full record on ClinicalTrials.gov
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