Who is eligible for clinical trial NCT03321656?

Participants must meet the protocol's inclusion criteria for End Stage Renal Disease. The stated age range is 18 Years to 75 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT03321656 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-19

Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile (NCT03321656)

🟢 Recruiting Phase2 / Phase3 💊 Investigational Drug / Biologic Sponsor: Roberto Gedaly

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (15 items).

Location: Deepa Valvi — Lexington, Kentucky

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Deepa Valvi — Lexington, Kentucky

📞 Contact the Study Coordinator

Phone: (859) 257-9443

Email: deepa.valvi@uky.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in End Stage Renal Disease

PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis — Washington D.C., District of Columbia
Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients — Dallas, Texas
An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL — Winnipeg, Manitoba
The Effect of a Prehabilitation Exercise Program on Physical Functioning for Patients Undergoing Kidney Transplantation — Vancouver, British Columbia
Light Therapy in End Stage Kidney Disease — Philadelphia, Pennsylvania
Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis — Boston, Massachusetts

Explore by condition: All End Stage Renal Disease clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗