ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
- Conditions
- Delayed Graft Function
- Interventions
- Other: Placebo
- Registration Number
- NCT05907096
- Lead Sponsor
- argenx
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 103
- Is at least the local legal age of consent for clinical studies and at least aged 18 years and less than 70 years
- Agree to use contraceptive measures consistent with local regulations
- Are diagnosed with ESRD and have been stable on chronic dialysis for at least 3 months
- Are recipients of de novo or second-time, single kidney transplant from a deceased donor, either DCD (donation after cardiac/circulatory death) or DBD ( (donation after brain death)
- Are ABO compatible with donor allograft, except for type A2 donor to type B recipient kidneys
- Have a negative cross match
- Have received pretransplant vaccinations for: Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae, or are willing to receive the vaccinations approximately 3 to 4 months posttransplant
- Any history of prothrombotic disorder or history of thrombosis or hypercoagulable state, excluding vascular access clotting
- Any known history of complement deficiency
- Evidence of peritonitis in participants on peritoneal dialysis
- Received any solid organ, bone marrow, or hematopoietic stem cell transplant, with the exception of prior first kidney transplant
- High risk within the study period for recurrence of underlying renal disease in the opinion of the investigator
- Clinically significant comorbidity, recent major surgery (within 3 months of screening), history of any treatment nonadherence, or intention to have surgery during the study other than kidney transplantation; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
- Clinically significant active bacterial, viral, or fungal infection
- History of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for 5 years or more before first study drug administration. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer
- History of current alcohol, drug, or medication abuse as assessed by the investigator
- Pregnant or lactating state or intention to become pregnant during the study
The full list of criteria can be found in the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARGX-117 ARGX-117 Patients receiving ARGX-117 intravenous infusions Placebo Placebo Patients receiving placebo intravenous infusions
- Primary Outcome Measures
Name Time Method eGFR at 24 weeks posttransplant Up to 24 weeks Estimated glomerular filtration rate
- Secondary Outcome Measures
Name Time Method Proportion of participants with Delayed Graft Function (DGF) Up to 52 weeks Proportion of participants with fDGF Up to 52 weeks Functional Delayed Graft Function
Duration of dialysis treatment for DGF within the first 30 days posttransplant up to 30 days Proportion of participants who have ongoing dialysis requirement at study day 31 Up to 31 days CRR at 72 hours posttransplant and on study day 8 up to 8 days Creatinine reduction ratio
iBox score at 52 weeks posttransplant up to 52 weeks Dialysis-free participant survival through 52 weeks posttransplant up to 52 weeks (Death-censored) allograft survival through 52 weeks posttransplant Up to 52 weeks eGFR at 52 weeks posttransplant up to 52 weeks Estimated glomerular filtration rate
Incidence of PNF up to 12 weeks Primary Nonfunction
Serum concentrations for ARGX 117 up to 64 weeks Changes from baseline in free C2, total C2, and CH50 up to 64 weeks Incidence of anti-drug antibodies (ADA) against ARGX-117 up to 64 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (45)
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
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
Scroll for more (35 remaining)Cedars-Sinai Medical Center🇺🇸Los Angeles, California, United States