ARGX-117 in Improving Allograft Function in Recipients of a Deceased Donor Renal Allograft

What is the Purpose of this Study?

This study focuses on people who have been matched to receive a kidney transplant. The study aims to determine whether an experimental drug called ARGX-117 will reduce the patient’s chances of needing dialysis after transplant and help improve kidney function. (The kidney transplant is not part of this study.) Participants will receive either ARGX-117 or placebo (inactive substance). Study procedures also include physical examination, electrocardiogram, and questionnaires. Antibodies are proteins that fight and prevent infections. ARGX-117 is an antibody that binds to specific proteins that are part of the immune system, called the complement system. These proteins have a central role in the body’s defense against infections. The complement system can sometimes become overactive and cause inflammation in the body, resulting in diseases that destroy organs and tissues. ARGX-117 may help reduce this inflammation.

Eligibility

* 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)

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.

Show less

Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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

Study Details

Disease Type/Condition

Other

Principal Investigator

Jordan, Stanley

Co-Investigators

Alice Peng, Ashley Vo, Edmund Huang, Jun Shoji, Noriko Ammerman, Reiad Najjar, Sindhu Chandran

Age Group

Adult

Phase

IRB Number

STUDY00003573

ClinicalTrials.gov ID

NCT05907096

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org