Clinical Research Directory
Browse clinical research sites, groups, and studies.
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)
Sponsor: argenx
Summary
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.
Official title: A Global, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC Administered by a Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-08-30
Completion Date
2027-09
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
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
Locations (23)
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