ARGX-117 in Deceased Donor Kidney Transplant Recipients At Risk for Delayed Graft Function

Description

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.

Conditions

Delayed Graft Function

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Study Overview

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Study Details

Study overview

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.

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 in Deceased Donor Kidney Transplant Recipients At Risk for Delayed Graft Function

Condition
Delayed Graft Function
Intervention / Treatment

-

Contacts and Locations

Tampa

Tampa General Hospital, Tampa, Florida, United States, 33606

Chicago

University of Illinois (UI) Health - Outpatient Care Center, Chicago, Illinois, United States, 60612

Livingston

Cooperman Barnabas Medical Center, Livingston, New Jersey, United States, 07039

Buffalo

Erie County Medical Center, Buffalo, New York, United States, 14215

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

argenx,

Study Record Dates

2026-12