Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Trans… (NCT03841097) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants
United States60 participantsStarted 2019-11-11
Plain-language summary
The primary purpose of this study is to evaluate the pulse wave velocity and vascular compliance measurements at the beginning and the end of the study while the participants are taking either extended release tacrolimus tablets (known by brand name Envarsus XR®, and also referred to as LCPT in this study) given once-daily each morning after transplantation or immediate release tacrolimus capsules (also known by brand name Prograf® or abbreviation IR-TAC in this study) that are administered twice-daily 12 hours apart after kidney transplantation. Pulse wave velocity and vascular compliance measurements are two non-invasive tests that are used to evaluate how well the blood vessels adapt to each heartbeat. The secondary purpose is to look at the effectiveness and safety of LCPT given once-daily compared to IR-TAC given twice-daily 12 hours apart after kidney transplantation.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess Change in Pulse Wave Velocity
Timeframe: baseline and months 12-24 post transplant
2
Assess Change in Vascular Compliance measurements
Timeframe: baseline and months 12-24 post transplant
3
Assess Change in Vascular Compliance
Timeframe: baseline and months 12-24 post transplant