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 @ 4:33 PM
Ignite Modification Date:
2025-12-24 @ 4:33 PM
NCT ID:
NCT01636466
Eligibility Criteria:
Inclusion Criteria:
* recipient of deceased or living donor kidney transplant
* Age 18-75 years (inclusive)
* Male or female
* renal allograft dysfunction/deterioration evidenced by glomerular filtration rate (GFR) less than or equal to 35
* Grade 2 or 3 Interstitial fibrosis/tubular atrophy (IF/TA) on renal allograft biopsy within 5 years of enrollment
* Willing and able to provide informed consent for study participation
Exclusion Criteria:
* Prior solid organ transplant (other than kidney)
* History of donor-specific antibody
* History of biopsy-proven acute rejection within 1 year prior to enrollment
* Proteinuria greater than or equal to 1.5 gm on spot urine protein/creatinine ratio
* Evidence of Hepatitis C virus infection (antibody positive or polymerase chain reaction(PCR) positive)
* Epstein Barr Virus (EBV) or cytomegalovirus (CMV) viremia at the time of enrollment
* Subjects receiving belatacept (Nulojix)
* Pregnant or nursing (lactating) women
* Women of child-bearing potential (WOCBP) who are unwilling or unable to use two birth-control methods throughout participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01636466
Study Brief:
Protocol Section:
NCT01636466