Can kidney transplant patients safely stop a key Anti-Rejection drug?
NCT ID NCT01517984
First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time
Summary
This study examines whether low-risk recipients of living-donor kidneys can safely reduce or stop tacrolimus, a drug that prevents rejection but can harm the kidneys over time. Participants first receive rabbit antithymocyte globulin and standard immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone. Those who avoid rejection in the first six months may have tacrolimus withdrawn while researchers track kidney function and immune response. The goal is to see if less immunosuppression can lower side effects without triggering rejection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tacrolimus withdrawal after rabbit antithymocyte globulin induction, with mycophenolate mofetil and prednisone
- What this could lead to
- If successful, this approach could give low-risk kidney transplant recipients a way to reduce or stop tacrolimus, easing its long-term side effects while keeping the donated kidney safe.
- What could go wrong
- Withdrawing tacrolimus may raise the risk of rejection, and this small Phase 2 trial stopped early, so the balance of benefits and risks remains uncertain.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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52 people
The number who actually took part.
- Start date
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Nov 2010
- Finished
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May 2015
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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Health Sciences Centre
Winnipeg, Manitoba, R3A IR9, Canada
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Mount Sinai School of Medicine
New York, New York, 10029, United States
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The Methodist Hospital
Houston, Texas, 77030, United States
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Toronto General Hospital
Toronto, Ontario, M5G 2M1, Canada
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University Hospitals of Cleveland
Cleveland, Ohio, 44106-5048, United States
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University of California Los Angeles
Los Angeles, California, 90055, United States
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University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
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Washington University
St Louis, Missouri, 63110, United States
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Yale University School of Medicine
New Haven, Connecticut, 06520-8029, United States
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Other studies related to the condition(s) this trial covers.
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