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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT01921218
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent
* Kidney transplant recipient (human leukocyte antigen (HLA) non-identical donor) who now has impaired renal allograft function with:
* Estimated glomerular filtration rate (GFR) \< 35 with a decline in GFR of \> 10% in the 12 months prior to enrollment and must have biopsy proven grade II or III interstitial fibrosis/tubular atrophy (IF/TA) OR
* Estimated GFR persistently \< 20 ml/min over the 6 month period prior to enrollment absent other causes for graft dysfunction, and deemed to have a failing allograft by the patient's transplant nephrologist
* On a maintenance immunosuppressive regimen that includes calcineurin inhibitor (CNI)(tacrolimus or cyclosporine) or sirolimus and at least
* MMF of a dose of at least 1 gm/day or comparable dose of azathioprine OR
* Prednisone at a dose of at least 5 mg/day
* Men and women, ages 18 to 70, inclusive
Exclusion Criteria:
* Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug.
* Women who are pregnant or breastfeeding.
* Women with a positive pregnancy test.
* Sexually active fertile men not using effective birth control if their partners are WOCBP.
* Subjects who are Epstein-Barr Virus (EBV) seronegative.
* Subjects with any prior solid organ (e.g., heart, liver, pancreas) or cell (e.g., islet, bone marrow) transplant other than a renal allograft. Exception may be made for recipient of a simultaneous kidney-pancreas transplant who had previously experienced graft loss of the pancreas allograft due to thrombosis or rejection.
* Subjects with presence of donor specific antibody at the time of enrollment
* Subjects who have a recent history (within 1 yr) of biopsy proven acute rejection \> Banff grade Ia
* Subjects who have a living donor identified for re-transplant within 3 months
* Subjects with a history of post-transplant lymphoproliferative disease (PTLD)
* Subjects at risk for tuberculosis (TB)
* Subjects with a history of cancer within the past 3 years, other than non-melanoma skin cancer(s)
* Subjects with a positive BK virus serum polymerase chain reaction (PCR) \> 20,000 copies at the time of enrollment OR history of biopsy-proven BK nephropathy within the year prior to enrollment.
* Subjects with a mammogram that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations
* Subjects who have difficult intravenous access or other reasons that would likely preclude the ability to receive long-term intravenous infusions
* Hypersensitivity to any medications that will be used in the protocol
* Subjects who have used any investigational drug within the 30 days prior to anticipated enrollment
* Subjects currently receiving belatacept as part of their maintenance immunosuppressive regimen
* Prisoners, or subjects who are involuntarily incarcerated.
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01921218
Study Brief:
Protocol Section:
NCT01921218