Comparing Envarsus XR® and Tacrolimus for Kidney Transplant Patients
Official title: Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
Run by University of Kentucky · NCT03321656 · Data updated 2026-11-12
This study is testing whether a new kidney medication called Envarsus XR® is safer and more effective than the standard medication tacrolimus for people getting a kidney transplant.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 78 (estimated) |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Status | Recruiting |
| Started | March 28, 2019 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT03321656 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with end stage renal disease who are fluent in English and listed for a primary solitary kidney transplant.
✕Probably not a fit
Patients who have previously undergone organ transplants or have significant infections or certain viral infections will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a single center, prospective, open-label, randomized, controlled trial that compares the safety and effectiveness of Envarsus XR® to twice-daily tacrolimus in patients with end stage renal disease who are listed for a primary solitary kidney transplant. Participants will be pre-screened and, if eligible, randomized to receive either Envarsus or tacrolimus starting on the first day after their transplant surgery. The study involves a total of 9 visits over 6 months, during which participants will complete medication diaries and undergo kidney biopsies to assess their immunologic response. The findings will be shared with regulatory agencies and the sponsoring company to inform future treatment options.
Why it matters
Potential benefit: If successful, this study could provide insights into a more effective immunosuppressive regimen for kidney transplant patients, potentially improving transplant outcomes.
How similar studies have gone: Other studies have shown promising results with similar immunosuppressive approaches, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Deepa Valvi
Lexington, Kentucky, United States Recruiting
Study contacts
- Principal investigator: Roberto Gedaly, MD — University of Kentucky
- Study coordinator: Deepa Valvi, DrPH
- Email: deepa.valvi@uky.edu
- Phone: 8592579443
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Ribupatide PK in People with Kidney Impairment
This study tests how a single shot of ribupatide behaves in the body for people with severe kidney problems compared to those with normal kidney function.
-
Intradiay dialysis exercise to improve posture in adults with end-stage kidney disease
This study tests whether a 12-week supervised exercise program done during dialysis can improve posture in adults on maintenance hemodialysis.
-
Pumpkin seed oil for people on hemodialysis
This study tests whether taking pumpkin seed oil daily for 3 months helps reduce inflammation and improve-related lab markers in people with end-stage kidney disease on dialysis.
-
Porcine thymokidney transplant for end-stage renal disease
This study tests whether a GalKO porcine thymokidney transplant can keep kidney function without dialysis in adults with end-stage kidney disease who are unlikely to get a standard donor kidney soon.
-
How inflammatory diseases change the way your body handles medicines.
This study will see if inflammatory conditions like type 2 diabetes, IBD, or end-stage kidney disease change how common medicines are processed and increase the chance of side effects.
-
CRISPR-edited donor kidney transplant to reduce rejection risk
This trial will see if donor kidneys edited with CRISPR to turn off key HLA genes can lower rejection in adults with end-stage kidney disease receiving transplants.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.