Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT04786067
Eligibility Criteria:
Inclusion Criteria:
* Adult (\>18 years) recipients of a kidney-only transplant, including re-transplants
* Non-HLA identical Living or Deceased Donor Grafts
* Able to provide informed consent
* Absence of donor specific antigens
* Stable renal function (eGFR\>40mL/min for 3 months prior to enrollment)
* Patients treated with Belatacept as part of de novo immunosuppression or converted to Belatacept with stable kidney function for 3 months (as stated above)
* Patients who underwent kidney transplantation at least 9 months prior to study entry
Exclusion Criteria:
* Prior or concurrent non-kidney organ transplants
* Presence of BK nephropathy in current graft
* Recipient on any other investigational drug in the 12 weeks prior to inclusion
* Patient with history of recent (\<3mo), recurrent, or severe (Banff Grade 2 or greater or unable to be treated with steroids) acute rejection episodes
* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
* Significant hepatic impairment
* Bilateral kidney transplantation
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04786067
Study Brief:
Protocol Section:
NCT04786067