Once-Daily pill may protect blood vessels better in black kidney transplant patients
NCT ID NCT03841097
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study looks at two versions of the drug tacrolimus, which is used to prevent organ rejection after a kidney transplant. One version is taken once a day, the other twice a day. The goal is to see which one does a better job at keeping blood vessels healthy, measured by how stiff they are. The study involves 60 African American kidney transplant recipients and will follow them for up to two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tacrolimus (extended-release and immediate-release forms)
- What this could lead to
- If successful, this could show that a once-daily version of tacrolimus is better for heart and blood vessel health than the twice-daily version in African American kidney transplant patients.
- What could go wrong
- This is a small, single-center study with only 60 participants, so results may not apply to all patients. The study is also observational in nature and does not test a new drug, so any benefits are about choosing between existing options.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2019
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
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: * Subjects who self-report their race/ethnicity as Black-non-Hispanic only (which may include self-reported African ancestry as African-American, Afro-Caribbean or African) * Subjects receiving a first or second deceased donor or living donor kidney transplant at the Hospital of the University of Pennsylvania * Subjects whose body mass index (BMI) ≥19 * Subjects who are sero-positive for Hepatitis B or C positive may also be enrolled. * Subjects whose concurrent immunosuppression at the time of transplant will be (generic or brand formulation) Mycophenolate mofetil (MMF, CellCept) or mycophenolic sodium (MPS, Myfortic®), either a standard prenisone taper or an early withdrawal protocol, and induction with rabbit-antithymocyte globulin (Thymoglobulin®). Exclusion Criteria: * Subjects who are greater than 75 years old * Known hypersensitivity to Tacrolimus and hydrogenated castor oil * Subjects who are not self-described as being of Black African descent and living in the United States * Subjects who self-report their race/ethnicity as Black-Hispanic or Multiracial * Subjects who are recipients of organ transplants other than kidney * Subjects who are recipients of third time or more kidney transplants * Subjects who are HIV positive at the time of pre-transplant screening * Subjects with recurrent focal segmental glomerulosclerosis (FSGS) * Subjects with any severe medical condition (including infection or severe liver disease) requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation * Subjects with WBC ≤ 2000/mm3 or ANC ≤ 1500 mm3 with PLT ≤ 75,000/mm3 or HGB \< 8 g/dL * Subjects with mental or physical conditions or known non-adherence (defined as documentation in the patient chart of multiple missed visits and/or medication doses) which in the investigator's opinion would interfere with the objectives of the study * Subjects who have been exposed to investigational therapy within 30 days prior to enrollment or five half-lives of the investigational product (whichever is greater). * Subjects with severe diabetic gastroparesis or other severe GI disturbances that could interfere with Tacrolimus absorption * Subjects who have underwent gastric bypass at any time pre transplant. * Pregnant or nursing (lactating) women subjects, where pregnancy is defined as a state of female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/ml). * Women subjects of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a double-barrier method of contraception, UNLESS they are * Women whose career, lifestyle, or sexual orientation preclude intercourse with a male partner * Women whose partners have been sterilized by vasectomy or other means
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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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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could removing catheters sooner after kidney transplant cut infections?
- Can a vaccine shield transplant patients from shingles?
- Can a single drug dose forecast transplant kidney health?
- Pre-Surgery bootcamp may boost kidney transplant recovery
- Simple bathroom habit may cut infection risk after kidney transplant