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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT00999258
Eligibility Criteria:
Inclusion Criteria:
* African American (self-identified) renal transplant recipients.
* Primary or re-transplant kidney-only recipients.
* Recipients on tacrolimus-based immunosuppression regimen.
* Time interval after transplant: at least 3 months but not greater than 5 years.
* Renal transplant recipients with 10% decrease in GFR from baseline.
* Women of childbearing potential must have a negative pregnancy test upon enrollment, and must consent to receive contraceptive counseling and to use effective contraception while enrolled in the study. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method.
Exclusion Criteria:
* GFR \<40ml/min.
* Urine protein-to-creatinine ratio \>0.5.
* Significant chronic allograft nephropathy grade 3 Banff score.
* Evidence of acute rejection episodes within the past 3 months.
* Evidence of active infection within the past month.
* Any malignancy except treated non-melanoma skin cancer within the past 3 years.
* Leucopenia \<2,000/mm3 within the past month.
* Thrombocytopenia \<100,000/mm3 within the past month.
* Total cholesterol \>300mg/dl, despite adequate treatment.
* Triglycerides \>500mg/dl, despite adequate treatment.
* Non-healed post-surgical or non-surgical wound.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00999258
Study Brief:
Protocol Section:
NCT00999258