Status:
ACTIVE_NOT_RECRUITING
Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants
Lead Sponsor:
Roy D. Bloom, MD
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Kidney Transplant; Complications
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 extende...
Detailed Description
There are several medicines that are given to kidney transplant patients to prevent the body's immune system from rejecting (not accepting) the transplanted kidney. Frequently, more than one medicine ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03841097
Start Date
November 11 2019
End Date
May 1 2026
Last Update
October 15 2025
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104