The main purpose of this study is to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function. The study consists of 2 parts: part A comprises the main study period, and part B comprises the long-term observational follow-up period. During part A, after the screening period, eligible participants will be randomized to receive either ARGX-117 or placebo, entering the treatment and evaluation period (duration of up to 52 weeks). After the treatment period, participants will enter a follow-up period of up to 12 weeks. The total study duration varies from approximately 64 weeks up to 5 years post-transplant depending on whether a participant enrols in part B of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
103
Intravenous administration of ARGX-117
Intravenous administration of placebo
Cedars-Sinai Medical Center
Los Angeles, California, United States
Tampa General Hospital
Tampa, Florida, United States
University of Illinois (UI) Health - Outpatient Care Center
Chicago, Illinois, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
Erie County Medical Center
Buffalo, New York, United States
eGFR at 24 weeks posttransplant
Estimated glomerular filtration rate
Time frame: Up to 24 weeks
Proportion of participants with Delayed Graft Function (DGF)
Time frame: Up to 52 weeks
Proportion of participants with fDGF
Functional Delayed Graft Function
Time frame: Up to 52 weeks
Duration of dialysis treatment for DGF within the first 30 days posttransplant
Time frame: up to 30 days
Proportion of participants who have ongoing dialysis requirement at study day 31
Time frame: Up to 31 days
CRR at 72 hours posttransplant and on study day 8
Creatinine reduction ratio
Time frame: up to 8 days
iBox score at 52 weeks posttransplant
Time frame: up to 52 weeks
Dialysis-free participant survival through 52 weeks posttransplant
Time frame: up to 52 weeks
(Death-censored) allograft survival through 52 weeks posttransplant
Time frame: Up to 52 weeks
eGFR at 52 weeks posttransplant
Estimated glomerular filtration rate
Time frame: up to 52 weeks
Incidence of PNF
Primary Nonfunction
Time frame: up to 12 weeks
Serum concentrations for ARGX 117
Time frame: up to 64 weeks
Changes from baseline in free C2, total C2, and CH50
Time frame: up to 64 weeks
Incidence of anti-drug antibodies (ADA) against ARGX-117
Time frame: up to 64 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Columbia University
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Royal Adelaide Hospital
Adelaide, Australia
Monash Health - Monash Medical Centre
Clayton, Australia
...and 35 more locations