ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function (Varvara)
- Conditions
- Delayed graft functionMedDRA version: 21.0Level: PTClassification code: 10076664Term: Delayed graft function Class: 100000004863MedDRA version: 21.1Level: LLTClassification code: 10048747Term: Renal graft function delayed Class: 10022117Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2022-503091-89-00
- Lead Sponsor
- Argenx
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 108
Is at least the local legal age of consent for clinical studies and at least aged 18 years and less than 70 years when signing the ICF, Have received SARS-CoV-2 vaccinations consistent with participating site’s requirements, Is capable of providing signed informed consent and complying with protocol requirements, Agree to use contraceptive measures consistent with local regulations, Have dry body weight less than 120 kg and body mass index less than 40 kg/m2 at screening, 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 or DBD, 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, Clinically significant active bacterial, viral, or fungal infection or infection with HBV, HCV, HIV or tuberculosis, 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, Received a different IMP in another clinical study less than 12 weeks or 5 half-lives (whichever is longer) before screening, Currently participating in another interventional clinical study, Previously participated in an ARGX-117 clinical study and received at least 1 dose of IMP, Known hypersensitivity to ARGX-117 or any of its excipients, Known hypersensitivity to tacrolimus, MMF or mycophenolic acid, or antithymocyte globulin or allergy to Leporidae (eg, rabbit), History (within 12 months before screening) of current alcohol, drug, or medication abuse as assessed by the investigator, Pregnant or lactating state or intention to become pregnant during the study, Received any prior desensitization therapies or any pretransplant immunosuppressive therapy within 5 half-lives or twice the duration of the biological effect, whichever is longer., 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, Current treatment for an autoimmune disease requiring maintenance immunosuppression to control systemic disease activity that would pose a significant safety risk or put the participant at undue harm in the opinion of the investigator, Any history of clinically significant arrythmia, known long QT syndrome, or clinically significant ECG abnormality at screening, including QTcF >450 ms for male participants and QTcF >470ms for female participants, Any history of malignancy unless considered cured by adequate treatment with no evidence of recurrence for more than 5 years before the first administration of IMP. Adequately treated participants with the following cancers can be included at any time: a. Basal cell or squamous cell skin cancer; b. Carcinoma in situ of the cervix; c. Carcinoma in situ of the breast; d. Incidental histological finding of prostate cancer, Unwillingness to receive vaccinations consistent with protocol-mandated and participating site requirements
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of ARGX-117 compared to placebo in improving allograft function in deceased donor kidney transplants at risk for DGF.;Secondary Objective: To evaluate the efficacy of ARGX-117 compared to placebo to reduce the risk of DGF, promote early recovery, and improve overall allograft function in deceased donor kidney transplants, To evaluate the safety and tolerability of ARGX-117 compared to placebo., To assess the PK of ARGX-117., To assess the PD of ARGX-117., To assess the immunogenicity of ARGX-117.;Primary end point(s): eGFR at 24 weeks posttransplant
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Proportion of participants with DGF;Secondary end point(s):Proportion of participants with fDGF;Secondary end point(s):Duration of dialysis treatment for DGF within the first 30 days posttransplant (ie, date of last dialysis treatment);Secondary end point(s):CRR at 72 hours and on study day 8 (posttransplant day 7);Secondary end point(s):iBox score at 52 weeks posttransplant;Secondary end point(s):Dialysis-free survival through 52 weeks posttransplant;Secondary end point(s):eGFR at 52 weeks posttransplant;Secondary end point(s):Safety outcomes, including AE and AESI monitoring, vital sign measurements, clinical laboratory tests;Secondary end point(s):Incidence of PNF;Secondary end point(s):Serum concentrations and PK parameters for ARGX-117;Secondary end point(s):Values and change from baseline in free C2, total C2, and CH50 activity;Secondary end point(s):Incidence and prevalence of ADA against ARGX-117