NCT03321656 Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
| NCT ID | NCT03321656 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Roberto Gedaly |
| Condition | End Stage Renal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2019-03-28 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 78 participants in total. It began in 2019-03-28 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.
Eligibility Criteria
Inclusion Criteria: * 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 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 * 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
Contact & Investigator
Roberto Gedaly, MD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT03321656 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying End Stage Renal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03321656 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03321656 currently recruiting?
Yes, NCT03321656 is actively recruiting participants. Contact the research team at deepa.valvi@uky.edu for enrollment information.
Where is the NCT03321656 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT03321656 clinical trial?
NCT03321656 is sponsored by Roberto Gedaly. The principal investigator is Roberto Gedaly, MD at University of Kentucky. The trial plans to enroll 78 participants.