Phase 4
N=56
Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XR™
Renal Transplant
Bottom Line
View on ClinicalTrials.gov: NCT04838288 ↗Enrolled (actual)
56
Serious AEs
1.8%
Results posted
Apr 2026
Primary outcome: Primary: Change in Cognitive Function-Global on Covid-19 Telephone Battery — 34; 9; 10; 10 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Change from Prograf to Envarsus XR (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognitive Function-Global on Covid-19 Telephone Battery |
34; 9; 10; 10; 44; 6 | — |
| PRIMARY Change in Cognitive Function-Global on RBANS |
— | — |
| SECONDARY Change in Cognitive Function on Trail Making Part A |
— | — |
| SECONDARY Change in Cognitive Function on Trail Making Part B |
— | — |
| SECONDARY Change in Quality of Life |
4 | — |
| SECONDARY Impression of Improvement by PGI |
44 | — |
| SECONDARY Impression of Improvement by CGI |
32 | — |
| SECONDARY Change of Quality of Sleep |
10 | — |
Summary
The purpose of this study is to assess cognitive outcome and quality of life in stable renal transplant patients treated with twice daily tacrolimus at baseline and after switching to Envarsus XL. The study is designed to see if switching patients from Tacrolimus to Envarsus treatment improves cognitive function.
Eligibility Criteria
Inclusion Criteria
- Patients must be able to understand English and provide written informed consent;
- Males and females between 18 and 70 years of age;
- Recipients of a primary or secondary kidney transplant 4 weeks to 10 years prior to screening;
- Patients receiving a stable dose (i.e., no dose adjustments) of TAC-IR for a minimum of 4-7 days at screening;
- Patients with a screening TAC-IR trough level of 3-9 ng/mL, measured between Day -7 to 0;
- Women of childbearing potential must have a negative urine pregnancy test at screening;
- Patients must be willing to commit to and comply with the schedule of study visits.
- The patient is not scheduled to begin any new medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food supplements (including grapefruit and pomegranate products), or medications listed in Appendix 1.
Exclusion Criteria
- Recipients of any transplanted organ other than kidney;
- Patients with an estimated glomerular filtration rate (eGFR) (MDRD4) 10 mg/day;
- Patients with an episode of biopsy-proven or suspected acute rejection that requires treatment within 3 months of screening;
- Patients who are being actively treated for cancer (with the exception of non-invasive basal cell or cutaneous squamous cell carcinoma);
- Patients known to be human immunodeficiency virus (HIV) positive;
- Patients with any form of current drug or alcohol abuse as assessed by the Investigator;
- Patients who were treated with any other investigational agent within 1 month prior to screening;
- Pregnant or nursing women or women planning to become pregnant, where pregnancy is defined as a state of the female patient after conception and until the termination of gestation, confirmed by a positive urine laboratory test; women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC birth control method; UNLESS they are:
- Women whose career, lifestyle, or sexual orientation preclude intercourse with a partner
- Women whose partners have been sterilized by medically approved means
Data sourced from ClinicalTrials.gov (NCT04838288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.