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

ARGX-117-2201

This is a phase 2 study to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function

2024-02-17

2026-04-01

2026-12-01

Recruiting

Early phase I

102

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 when signing the ICF * 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 * Have received SARS-CoV-2 vaccinations consistent with participating site's requirements Exclusion Criteria: * 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 * 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 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: 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 * Unwillingness to receive vaccinations consistent with protocol-mandated and participating site requirements * 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 or 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 or 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. The full list is available in the protocol.

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2024-05-07