Status:
RECRUITING
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
Lead Sponsor:
Roberto Gedaly
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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 dise...
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 inves...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Previously undergone organ, tissue or cell transplant
- Allergic to Tacrolimus or MMF (Cellcept)
- Chronic use of blood thinners
- Previous chronic use of glucocorticoids or other immunosuppression, or biologic immunomodulators (prescribed for the treatment of serious inflammatory disorders)
- Significant or active infection
- Diagnosed with HIV, Hepatitis B or C, Herpes simplex virus, Varicella-Zoster virus, Epstein-Barr virus
- Have or have had cancer with in the past 3 years
- Have taken part in another study that involved an investigational drug within the last 12 months.
- Have a history of delayed or abnormal wound healing
- Are pregnant or breastfeeding
- Had a transfusion within the past 3 months
- Have or plan to be receive a live vaccination (intranasal influenza measles, mumps, rubella, oral polio, yellow fever, varicella)
- Are unable or unwilling to comply with study protocol or procedures.
- Current use anticoagulation medication
Key Trial Info
Start Date :
March 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT03321656
Start Date
March 28 2019
End Date
March 31 2026
Last Update
March 17 2025
Active Locations (1)
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1
Deepa Valvi
Lexington, Kentucky, United States, 40536