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:
NCT02560558
Eligibility Criteria:
Inclusion Criteria:
* Adult (age ≥18 years currently),
* First-time renal transplant recipients of either living donor or deceased donor,
1. who were initiated on belatacept at the time of transplant and
2. are at least one year post-transplant and off CNI therapy for at least 6 months.
* Patients at low immunologic risk, defined as
1. patients with a first transplant who have a PRA \< 50 against class I and class II antigens,
2. no DSA (donor-specific antibodies),
3. who have not had more than one episode of rejection, and
4. no episodes of rejection within the last 6 months prior to enrollment, and
5. no rejection with a grade of IIB or above.
Exclusion Criteria:
* Not first renal transplant, or multi-organ transplant recipient
* History of greater than one episode of biopsy-proven acute rejection, or of rejection of Banff 97 grade IIB or greater, or rejection within the last 6 months.
* Pregnancy (women of childbearing potential must use adequate contraception during study)
* Unwilling to receive all belatacept infusions at the Emory Transplant Center
* Calculated Glomerular Filtration Rate (GFR) less than 35.
* Serum creatinine at enrollment over 30% higher than 3 months (±4 weeks) prior to randomization
* HbA1C greater than 8 at enrollment
* Recent history of significant proteinuria (protein/Cr ratio \>1)
* Non-standard belatacept dosing (e.g. dose other than 5 mg belatacept/kg body weight)
* Cellcept dose less than 500 mg po bid.
* Prednisone dose greater than 5mg po qd within 3 months of randomization
* Patients not currently taking prednisone
* Active infection, or antibiotic or antiviral drug therapy within 1 month of randomization
* Evidence of Cytomegalovirus (CMV) viremia or clinical CMV infection within last 3 months.
* Polyomavirus BK PCR (polymerase chain reaction) load greater then 4.3 (copy number greater than 20,0000) within 3 months of randomization
* Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing not required)
* Known HIV (human immunodeficiency virus infection) (testing not required)
* Presence of donor specific antibody by Luminex single antigen assessment, or panel reactivity (PRA) above 50%.
* History of substance abuse or psychiatric disorder not compatible with study adherence and follow up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02560558
Study Brief:
Protocol Section:
NCT02560558