Overview
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
Eligibility
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.