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ACTIVE NOT RECRUITING
NCT03841097
PHASE4

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

Sponsor: Roy D. Bloom, MD

View on ClinicalTrials.gov

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.

Official title: A Phase IV, Prospective, Randomized, Open-label, Comparative Analysis, Single-center Study of Pulse Wave Velocity Evaluation, Tacrolimus TTR and Co-efficient of Tacrolimus Variation of African American Kidney Recipients Receiving Standard of Care Immediate Release Tacrolimus Capsules or Extended Release Tacrolimus Tablets

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2019-11-11

Completion Date

2026-05

Last Updated

2025-10-15

Healthy Volunteers

No

Interventions

DRUG

Extended Release Tacrolimus Tablets

The primary objective is to assess the change in pulse wave velocity (PWV) and vascular compliance measurements from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.

DRUG

Immediate Release Tacrolimus Capsule

The primary objective is to assess the change in pulse wave velocity (PWV) and vascular compliance measurements from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.

Locations (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States