Delayed Graft Function
Conditions
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.
Interventions
BIOLOGICALARGX-117
Intravenous administration of ARGX-117
OTHERPlacebo
Intravenous administration of placebo
Sponsors
argenx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eGFR at 24 weeks posttransplant | Up to 24 weeks | Estimated glomerular filtration rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, France, Italy, Portugal, Spain, Sweden, United States
Outcome results
None listed