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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT02743793
Eligibility Criteria:
Inclusion Criteria:
* Recipient of single organ liver or kidney allograft from a living or deceased donor;
* At screening, operationally tolerant, as defined by:
* Absence of any immunosuppressive therapy for ≥52 weeks prior to the screening visit, and
* No evidence of allograft rejection in the 52 weeks prior to the screening visit, based on the allograft recipient's medical history.
* Normal allograft function, defined as:
* For liver transplant recipients: Liver function tests (ALT, GGT) both less than or equal to the upper limit of normal (ULN); and,
* For kidney transplant recipients: Serum creatinine value corresponds to an estimated GFR \> 45 ml/min/1.73 m\^2.
* Receiving regular follow-up for a kidney or liver transplant by a local physician:
--Participants must be willing to allow the study team to contact and share medical information with this local physician.
* Ability to sign informed consent.
Exclusion Criteria:
* Current malignancy requiring recent surgery, ongoing chemotherapy, or radiation;
* Transplant of another organ;
* Current drug or alcohol dependency;
* Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; and
* Inability to comply with the study visit schedule and required assessments.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02743793
Study Brief:
Protocol Section:
NCT02743793