Efgartigimod PH20 SC - prefilled syringe: Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo PH20 SC - prefilled syringe: Subcutaneous placebo PH20 SC given by prefilled syringe
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.
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham (UAB) Hospital | Birmingham | Alabama | |
| Cedars-Sinai Medical Center | Los Angeles | California | |
| University of Chicago Medical Center | Chicago | Illinois | |
| University of Nebraska Medical Center | Omaha | Nebraska | |
| Duke University Hospital | Durham | North Carolina | |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | |
| Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center | Richmond | Virginia | |
| University of Washington Medical Center | Seattle | Washington | |
| 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 |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06503731 on ClinicalTrials.gov ↗ ← All trials in the USA