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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Subcutaneous placebo PH20 SC given by prefilled syringe
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
...and 13 more locations
Incidence of Adverse Events (AEs)
Time frame: Up to 78 weeks
Percentage of participants with permanent treatment discontinuation due to adverse events (AEs)
Time frame: Up to 48 weeks
Changes from baseline (slope) of the estimated glomerular filtration rate (eGFR)
Time frame: Up to 72 weeks
Histological changes in kidney biopsy
Time frame: Up to 72 weeks
Urine protein creatinine ratio (UPCR)
Time frame: Up to 72 weeks
Graft and participant survival
Time frame: Up to 72 weeks
Proportion of participants with biopsy-proven histologic resolution (BPHR) over time
Time frame: Up to 72 weeks
Changes from baseline in AMR/MVI index score over time
MVI: microvascular inflammation. AMR/MVI score is a continuous index derived from Banff histological lesions (g, ptc, cg, and C4d positivity) and used to quantify the intensity of microvascular inflammation linked to AMR. It aims to describe where a biopsy lies along the spectrum from no rejection to probable AMR to complete AMR/MVI, providing a more granular measure of disease severity than dichotomous Banff categories.
Time frame: Up to 72 weeks
Percentage change from baseline in total IgG levels in serum over time
Time frame: Up to 60 weeks
Efgartigimod serum concentration-time profile and PK parameter Ctrough
Time frame: Up to 48 weeks
Incidence of antidrug antibodies (ADA) against efgartigimod in serum over time
Time frame: Up to 72 weeks
Incidence of antibodies against rHuPH20 in plasma over time
Time frame: Up to 72 weeks
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