Status:
TERMINATED
Immune Monitoring and CNI Withdrawal in Low Risk Recipients of Kidney Transplantation
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Clinical Trials in Organ Transplantation
Conditions:
Kidney Transplant Recipients
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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transplanted kidneys work and the response of people's immune systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn.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 ...
Detailed Description
Kidney transplantation is a treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it functioning for a long...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01517984
Start Date
November 1 2010
End Date
May 1 2015
Last Update
September 11 2017
Active Locations (11)
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1
University of California Los Angeles
Los Angeles, California, United States, 90055
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8029
3
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
4
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109