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 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT02327403
Eligibility Criteria:
Inclusion Criteria:
1. Male or female adult kidney transplant recipients older than 18 years old
2. eGFR ≥30 ml/min
3. ≥6 months after transplantation
4. Proteinuria ≥1 gram/day in spot urine protein/creatinine ratio
5. Ability to provide written informed consent for the study.
6. Maintenance immunosuppression of CNI (cyclosporine or tacrolimus), antiproliferative agent (azathioprine, MMF or MPA) with either steroids or not.
Exclusion Criteria:
1. Age \<18 years
2. eGFR\<30 ml/min
3. active acute cellular rejection (ACR; higher than borderline) or ACR in the previous 6 months; active acute antibody-mediated rejection
4. recurrent FSGS
5. EBV IgG negative
6. patient on mTOR inhibitor (e.g. Everolimus, Sirolimus)
7. patient only on CNI (cyclosporine or tacrolimus) and steroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02327403
Study Brief:
Protocol Section:
NCT02327403