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:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT04177095
Eligibility Criteria:
Inclusion Criteria:
* Age minimum 18 years
* Written informed consent
* Single kidney transplant recipient (i.e. no combined organ transplants)
* Treated with de novo belatacept since transplantation (i.e. no previous use of calcineurin inhibitor or mTOR inhibitor for the current transplant)
* At least 1 year after transplantation or after initiation of belatacept
* Stable renal function (eGFR \> 40 ml/min continuously during previous 6 months)
* Blood biomarkers indicate immune quiescence (for Allosure this corresponds to dd-cfDNA \< 1%; for Trugraf this corresponds to "TX" signature)
* No history of BK viremia in current allograft
Exclusion Criteria:
* History of biopsy-proven acute rejection
* Presence of donor-specific antibodies (at any MFI)
* Spot urine protein/creatinine ratio \> 0.5 g/g
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04177095
Study Brief:
Protocol Section:
NCT04177095