Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XRâ„¢ (NCT04838288) | Clinical Trial Compass
CompletedPhase 4
Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XRâ„¢
United States56 participantsStarted 2021-06-22
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) \< 25 mL/min at screening;
✕. Patients with significant visual impairments affecting their ability to complete the study requirements and assessments: patient's vision is 20/200 or worse;
What they're measuring
1
Change in Cognitive Function-Global on Covid-19 Telephone Battery
. Patients with significant hearing impairments affecting their ability to complete the study requirements and assessments, based on Investigator discretion;
✕. Patients with any severe medical condition (including infection) requiring acute or chronic treatment that in the Investigator's opinion would interfere with study participation;
✕. Patients who have a history of any of the following, based on documentation of clinical conditions and concomitant medications in the medical records:
✕. Patients with medical history of hypertension or diabetes which is unmanageable by medically approved intervention (e.g., medication/diet) as assessed by the Investigator;
✕. Patients with acute or chronic depression, corresponding to a score of ≥20 (corresponding to moderate depression) on the BDI-II at screening;