Immune Monitoring and CNI Withdrawal in Low Risk Recipients of Kidney Transplantation

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will compare how well transplanted kidneys work and the response of people's immune systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn. In addition, this research study will evaluate whether reducing immunosuppression can decrease some of these side effects while still preventing rejection of the kidney.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Clinical Trials in Organ Transplantation
• Treatments: Antilymphocyte Serum; Calcineurin Inhibitors; Immunosuppressive Agents; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Tacrolimus; Thymoglobulin

Criteria

INCLUSION CRITERIA -

Initial Enrollment/Screening: Patients who meet all of the following criteria are eligible for enrollment as study subjects:

• Subject must be able to understand and provide written informed consent;

• Primary living-donor (related or unrelated) kidney transplant recipients;

• Peak flow-based PRAs for class I and class II <30%(performed by local center);

• Current (within 8 weeks prior to transplantation) flow-based PRAs for class I and class II <30% (performed by local center);

• No donor specific antibody by flow solid phase method on the peak PRA serum (if serum available), or on the current PRA serum (within 8 weeks prior to transplantation) performed by central core laboratory. If the sera for the peak PRA is not available, then only the current PRA serum will be tested;

• Negative T-cell and B-cell crossmatch by flow cytometry (performed by local center);

• Female subjects of childbearing potential must have a negative pregnancy test (urine or serum) upon study entry;

• Female and male subjects with reproductive potential must agree to use FDA approved methods of birth control while participating in the study.

Inclusion Criteria for Randomization:

Participants who meet all of the following criteria are eligible for randomization:

• No history of acute rejection episodes;

• The pre-randomization protocol biopsy should confirm no rejection, including borderline rejection (based on the central pathology read);

• No donor specific antibody as detected by flow solid phase method (performed by the central core laboratory).

EXCLUSION CRITERIA -

Initial Enrollment/Screening:

Participants who meet any of these criteria are not eligible for enrollment as study subjects:

• Recipient of multiple organ transplants;

• Prior history of organ transplantation;

• Deceased-donor source;

• Any condition that would preclude protocol biopsies;

• HLA identical recipients;

• Currently breast-feeding or plans to become pregnant during the timeframe of the study follow up period;

• Any condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements;

• Inability or unwillingness to comply with study protocol;

• Use of investigational drugs within 4 weeks of study entry and for the duration of the study;

• Recent recipient of any licensed or investigational live attenuated vaccine(s) within two months of prior to study entry.

Exclusion Criteria for Randomization:

Participants who meet any of these criteria are not eligible for randomization:

• Subjects who receive less than 4.5mg/kg of Rabbit ATG (Thymoglobulin®) induction therapy;

• Subjects who test positive for BKV by PCR in the blood at 6 months post-transplant;

• Any condition that would preclude protocol biopsies;

• Currently breast-feeding or plans to become pregnant during the timeframe of the study follow up period;

• Any condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements;

• Inability or unwillingness of a subject to give written informed consent or comply with study protocol;

• Use of investigational drugs within 4 weeks of study entry and for the duration of the study;

• Subjects who receive less than 1500 mg daily of Mycophenolate Mofetil (CellCept®) or equivalent.