Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roy D. Bloom, MD
• Collaborator: Veloxis Pharmaceuticals
• Treatments: Mycophenolic Acid; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• Subjects who are African American (Self-reported patients of Black African descent who live in the United States)

• Subjects receiving a first or second deceased donor or living donor kidney transplant at the Hospital of the University of Pennsylvania

• Subjects whose concurrent immunosuppression at the time of transplant will be (generic or brand formulation) Mycophenolate mofetil (MMF, CellCept®) or mycophenolic sodium (MPS, Myfortic®), prednisone and induction with rabbit-antithymocyte globulin (Thymoglobulin®)

Exclusion Criteria:

• Subjects who are greater than 75 years old

• Subjects who are not self-described as being of Black African descent and living in the United States

• 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)