Actively Recruiting
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
Led by Roberto Gedaly · Updated on 2026-03-24
78
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
Sponsors
R
Roberto Gedaly
Lead Sponsor
V
Veloxis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fluent in English and able to understand and provide informed consent
- Diagnosed with end stage renal disease and listed for primary solitary kidney transplant
- Willing to participate and follow study requirements with signed informed consent
- Females of childbearing potential agree to use two medically accepted contraception methods during the study and for one year after
You will not qualify if you...
- Prior organ, tissue, or cell transplant
- Allergy to Tacrolimus or MMF (Cellcept)
- Chronic use of blood thinners
- Previous long-term use of glucocorticoids, other immunosuppressants, or biologic immunomodulators for serious inflammatory disorders
- Significant or active infections
- Diagnosis of HIV, Hepatitis B or C, Herpes simplex virus, Varicella-Zoster virus, or Epstein-Barr virus
- Cancer within the past 3 years
- Participation in another investigational drug study within the last 12 months
- History of delayed or abnormal wound healing
- Pregnant or breastfeeding
- Blood transfusion within the past 3 months
- Have received or plan to receive live vaccinations (intranasal influenza, measles, mumps, rubella, oral polio, yellow fever, varicella)
- Unable or unwilling to comply with study protocol or procedures
- Current use of anticoagulation medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Deepa Valvi
Lexington, Kentucky, United States, 40536
Actively Recruiting
Research Team
D
Deepa Valvi, DrPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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