ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-02-17
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05907096

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is at least the local legal age of consent for clinical studies and at least aged 18 years and less than 70 years
  2. * Agree to use contraceptive measures consistent with local regulations
  3. * Are diagnosed with ESRD and have been stable on chronic dialysis for at least 3 months
  4. * 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)
  5. * Are ABO compatible with donor allograft, except for type A2 donor to type B recipient kidneys
  6. * Have a negative cross match
  7. * 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
  1. * Any history of prothrombotic disorder or history of thrombosis or hypercoagulable state, excluding vascular access clotting
  2. * Any known history of complement deficiency
  3. * Evidence of peritonitis in participants on peritoneal dialysis
  4. * Received any solid organ, bone marrow, or hematopoietic stem cell transplant, with the exception of prior first kidney transplant
  5. * High risk within the study period for recurrence of underlying renal disease in the opinion of the investigator
  6. * 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
  7. * Clinically significant active bacterial, viral, or fungal infection
  8. * 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
  9. * History of current alcohol, drug, or medication abuse as assessed by the investigator
  10. * Pregnant or lactating state or intention to become pregnant during the study

Contacts and Locations

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
University of Illinois (UI) Health - Outpatient Care Center
Chicago, Illinois, 60612
United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Erie County Medical Center
Buffalo, New York, 14215
United States
Columbia University
New York, New York, 10032
United States
The Ohio State University
Columbus, Ohio, 43210
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 10267
United States

Collaborators and Investigators

Sponsor: argenx

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-17
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2024-02-17
Study Completion Date2026-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Delayed Graft Function