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RECRUITING
NCT03321656
PHASE2/PHASE3

Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile

Sponsor: Roberto Gedaly

View on ClinicalTrials.gov

Summary

This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2019-03-28

Completion Date

2027-03-31

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

DRUG

Tacrolimus

0.1-0.2 mg/kg/day orally divided into two doses every 12 hours orally

DRUG

Envarsus XR

0.07-0.14 mg/kg/day every morning orally

Locations (1)

Deepa Valvi

Lexington, Kentucky, United States