NCT05907096Active, not recruitingPhase 2
A Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Efficacy, and Tolerability of ARGX-117 in Improving Allograft Function in Recipients of a Deceased Donor Renal Allograft at Risk for Delayed Graft Function
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- argenx
- Enrollment
- 103
- Locations
- 46
- Primary Endpoint
- eGFR at 24 weeks posttransplant
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
ARGX-117
Experimental
Patients receiving ARGX-117 intravenous infusions
Intervention: ARGX-117 (Biological)
Placebo
Placebo Comparator
Patients receiving placebo intravenous infusions
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
eGFR at 24 weeks posttransplant
Time Frame: Up to 24 weeks
Estimated glomerular filtration rate
Secondary Outcomes
- Proportion of participants with Delayed Graft Function (DGF)(Up to 52 weeks)
- Proportion of participants with fDGF(Up to 52 weeks)
- 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)
- 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)
- Incidence of PNF(up to 12 weeks)
- 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)
Investigators
Study Sites (46)
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