A phase IV prospective randomized open-label single-center study of pulse wave velocity evaluation tacrolimus time in therapeutic range and co-efficient of tacrolimus variation of African American kidney transplant recipients receiving immediate release tacrolimus capsules (IR-Tac) or extended release tacrolimus tablets (LCPT)
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- STATUS
- Enrolling By Invitation
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- participants needed
- 60
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 patient is taking either Envarsus XR® (extended release tacrolimus) tablets administered once-daily after transplantation or immediate release generic tacrolimus capsules that are administered twice-daily after kidney transplantation. Pulse wave velocity and vascular compliance measurements are two non-invasive tests that are used to evaluate how well patients blood vessels adapt to each heartbeat. The secondary purpose is to look at the effectiveness and safety of extended release tacrolimus tablets administered once-daily compared to generic tacrolimus capsules administered twice-daily after kidney transplantation.
Details
| Condition | Kidney Transplant; Complications |
|---|---|
| Age | 99years or below |
| Clinical Study Identifier | 03841097 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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