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



Status:Terminated
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2010
End Date:May 2015

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Immune Monitoring and Calcineurin Inhibitor (CNI) Withdrawal in Low Risk Recipients of Kidney Transplantation

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immune systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn.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.

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 time. Transplant recipients take immunosuppression (anti-rejection)
drugs to prevent their body from rejecting the new kidney. These drugs are used to prevent
the immune system from attacking the transplanted kidney. All anti-rejection medications
have unwanted side effects. The purpose of this study is to evaluate the safety of slowly
removing tacrolimus, a CNI.

POST STUDY TERMINATION NOTE: Although the investigators were unable to assess the primary
study end point due to early study termination,this trial supports the conclusion that risks
associated with acute rejection and donor-specific antibodies outweigh any potential
benefits of tacrolimus withdrawal, even in this highly selected, low-risk cohort of living
donor recipients treated with antithymocyte globulin induction.

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.
We found this trial at
10
sites
11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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Ann Arbor, Michigan 48109
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Houston, Texas 77030
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Houston, TX
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New York, New York 10029
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Winnipeg, Manitoba
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