Comparing Envarsus XR® and Tacrolimus for Kidney Transplant Patients
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
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 |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT03321656 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with end stage renal disease who are fluent in English and listed for a primary solitary kidney transplant.
Not a fit: Patients who have previously undergone organ transplants or have significant infections or certain viral infections will not benefit from this study.
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 performed: Other studies have shown promising results with similar immunosuppressive approaches, indicating potential for success in this trial.
Eligibility criteria
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 this trial is running
Lexington, Kentucky
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.