Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
Who is this study for? Patients with End Stage Renal Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Fluent in English able to understand and provide informed consent.
• End stage renal disease listed for primary solitary kidney transplant.
• Willing to participate in the study and comply with study requirements as evidenced by signed IRB-approved informed consent.
• Female who are of childbearing potential will be asked to use 2 different medically acceptable methods of contraception for the duration of the study and at least 1 year post-infusion.
Locations
United States
Kentucky
Deepa Valvi
RECRUITING
Lexington
Contact Information
Primary
Deepa Valvi, DrPH
deepa.valvi@uky.edu
8592579443
Time Frame
Start Date: 2019-03-28
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 78
Treatments
Active_comparator: Tacrolimus
0.1 - 0.2 mg/kg/day in 2 divided doses every 12 hours orally
Experimental: Envarsus XR
0.07-0.14 mg/kg/day every morning orally
Related Therapeutic Areas
Sponsors
Leads: Roberto Gedaly
Collaborators: Veloxis Pharmaceuticals