NCT03321656

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Roberto Gedaly · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be identified through the Department of Transplantation Surgery at the University of Kentucky. Participants will be pre-screened by the department for entry into the study. The investigator will determine if the participant meets study eligibility requirements. The purpose of this research is to gather information on how safe and effective of Envarsus® is when compared to twice-daily tacrolimus. The results of this study will be shared with the company providing financial support for the study, the Food and Drug Administration and other federal agencies, if required. All participants that successfully meeting inclusion criteria will be randomized (like the flipping of coin) to Envarsus vs. Tacrolimus at the time of transplant. Participants will be randomized to one of two treatment arms. Treatment begins on post-op day 1. * Treatment: Envarsus® 0.07-0.14 mg/kg/day every morning * Control: Generic tacrolimus 0.1-0.2 mg/kg/day in 2 divided doses given every 12 hours The total amount of time a person will be asked to volunteer for this study is 9-18 hours over the next 6 months. Participants will need to complete 9 study visits each of these visits will take approximately 1-2 hours to complete. Participants will be given medication dosing diaries to complete throughout the study and will undergo 2 kidney biopsies. Participants will be screened for HIV, Hepatitis B and Hepatitis C viruses.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-03-28
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2017-10-26
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study