🏛️ Verified NIH Record • Updated 2026-03-16

ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function (NCT05907096)

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

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: argenx

🩺 Plain-English Summary (8th-Grade Level)

The main purpose of this study is to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function. The study consists of 2 parts: part A comprises the main study period, and part B comprises the long-term observational follow-up period. During part A, after the screening period, eligible participants will be randomized to receive either ARGX-117 or placebo, entering the treatment and evaluation period (duration of up to 52 weeks). After the treatment period, participants will enter a follow-up period of up to 12 weeks. The total study duration varies from approximately 64 weeks up to 5 years post-transplant depending on whether a participant enrols in part B of the study.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (11 items).

Location: Cedars-Sinai Medical Center — Los Angeles, California

Age range: 18 Years to 70 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (45 Sites)

Showing the first 25 of 45 sites.

  • Cedars-Sinai Medical Center — Los Angeles, California
  • Tampa General Hospital — Tampa, Florida
  • University of Illinois (UI) Health - Outpatient Care Center — Chicago, Illinois
  • Cooperman Barnabas Medical Center — Livingston, New Jersey
  • Erie County Medical Center — Buffalo, New York
  • Columbia University — New York, New York
  • The Ohio State University — Columbus, Ohio
  • University of Texas Southwestern Medical Center — Dallas, Texas
  • Royal Adelaide Hospital — Adelaide,
  • Monash Health - Monash Medical Centre — Clayton,
  • Princess Alexandra Hospital — Woolloongabba,
  • Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck — Innsbruck,
  • Allgemeines Krankenhaus der Stadt Wien (AKH Wien) — Vienna,
  • Universitair Ziekenhuis Leuven — Leuven,
  • Centro Hospitalar e Universitario de Coimbra — Coimbra,
  • Hospital Geral de Fortaleza — Fortaleza,
  • Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer — Porto Alegre,
  • Hospital de Base — São Jose Do Rio Preto,
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP) — São Paulo,
  • Hôpital Maisonneuve-Rosemont - Centre de recherche — Montreal,
  • McGill University Health Centre - Royal Victoria Hospital — Montreal,
  • Vancouver Coastal Health - Vancouver General Hospital Diamond Healthcare Centre — Vancouver,
  • Providence Health Care - St. Pauls Hospital — Vancouver,
  • CHU Bordeaux - Groupe Hospitalier Pellegrin — Bordeaux,
  • Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Henri Mondor — Créteil,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Delayed Graft Function

Explore by condition: All Delayed Graft Function clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗