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Evaluating ARGX-117 for kidney transplant recipients at risk for delayed graft function

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

Phase 2 Interventional argenx · NCT05907096

This study is testing a new treatment called ARGX-117 to see if it can help kidney transplant recipients who are at risk for delayed graft function feel better after their surgery.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment102 (estimated)
Ages18 Years to 70 Years
SexAll
Sponsorargenx Industry-sponsored
Locations45 sites (Los Angeles, California and 44 other locations)
Trial IDNCT05907096 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, efficacy, and tolerability of ARGX-117 in patients who have received a kidney transplant from deceased donors and are at risk for delayed graft function. Participants will be randomized to receive either ARGX-117 or a placebo during a treatment period of up to 52 weeks, followed by a follow-up period of up to 12 weeks. The study consists of two parts: the main study period and a long-term observational follow-up. The total duration of participation may vary from approximately 64 weeks to 5 years post-transplant, depending on enrollment in the follow-up phase.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 70 who are receiving their first or second kidney transplant from a deceased donor and are at risk for delayed graft function.

Not a fit: Patients with a history of prothrombotic disorders or thrombosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve kidney transplant outcomes and reduce the incidence of delayed graft function in recipients.

How similar studies have performed: Other studies have explored similar interventions in transplant recipients, but the specific approach of using ARGX-117 in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Los Angeles, California and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Delayed Graft Function
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.