PTAAK- 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)

PTAAK- 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)
Recruiting
18 years - 75 years
All
Phase 4
60 participants needed
1 Location

Brief description of study

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 in African American kidney transplant recipients 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.

Detailed description of study


Patients will remain in the study for up to 12 months during which time they will be seen for monthly clinic visits, and complete labs per the standard of care.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Kidney Transplant
  • Age: 18 years - 75 years
  • Gender: All

Self-described African Americans receiving a first time or second time deceased donor or living donor kidney transplant at the Hospital of the University of Pennsylvania

Updated on 04 Aug 2024. Study ID: 832046

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