Clinical Research Directory
Browse clinical research sites, groups, and studies.
Back to Studies
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
Conditions
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