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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT03266393
Eligibility Criteria:
Inclusion Criteria:
* Recipients of first kidney transplants (deceased or living donor) with stable allograft function
* 6 or more months after transplantation
* Currently on a stable dose of twice-daily tacrolimus and mycophenolate mofetil (MMF) or enteric coated mycophenolic acid (EC-MPA)± corticosteroids for a minimum of 6 months prior (patient has remained on a dosing that has changed no greater than ± 0.5mg/dose for a minimum of 4 months)
* Ability to comply with study procedures for the entire length of the study
* Patient and/or parent/legal guardian has been informed about the study survey and has signed an informed consent form.
Exclusion Criteria:
* Detectable donor specific anti-HLA antibody prior to enrollment (pre- or post-transplant)
* Actively being treated for an episode of biopsy proven acute cellular rejection (ACR) (Banff 1A or greater)
* Post-transplant history of biopsy proven ACR (Banff 1B or greater) or antibody mediated rejection (AMR)
* Currently receiving, planning to receive, or received within 7 days prior to study enrollment any drug interacting or interfering with tacrolimus metabolism (azole antifungals, erythromycin, clarithromycin, diltiazem, protease inhibitors, statins, grapefruit juice, rifampin or anti-seizure medications shown to interact with tacrolimus)
* Currently receiving an mTOR inhibitor (sirolimus, everolimus)
* Gastrointestinal illness that might affect the absorption of tacrolimus
* Unable or unwilling to complete study survey questionnaire
* Professional care taker is responsible for dispensing subject's medication
* Recipient of HLA identical or zero HLA mismatched organ transplant
* Documented history of medication non-adherence following transplantation prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
20 Years
Study:
NCT03266393
Study Brief:
Protocol Section:
NCT03266393