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
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Combination product, Other
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama at Birmingham (UAB) Hospital
RECRUITING
Birmingham
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
North Carolina
Duke University Hospital
RECRUITING
Durham
Ohio
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Virginia
Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center
RECRUITING
Richmond
Washington
University of Washington Medical Center
RECRUITING
Seattle
Other Locations
Austria
Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin
RECRUITING
Bordeaux
Centre Hospitalier Universitaire (CHU) de Grenoble Alpes - Hôpital Michallon
RECRUITING
La Tronche
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil
RECRUITING
Toulouse
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Universitätsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Spain
Hospital Del Mar
RECRUITING
Barcelona
Hospital Universitario de Bellvitge
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date:2024-08-30
Estimated Completion Date:2027-09
Participants
Target number of participants:30
Treatments
Experimental: Treatment arm 1
Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids)
Experimental: Treatment arm 2
Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) up to week 24 followed by placebo PH20 SC on top of optimized standard background immunosuppression therapy from weeks 24 to 48
Placebo_comparator: Treatment arm 3
Participants receiving Placebo PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids)