Converting Elderly Kidney Transplant Recipients From Tacrolimus to Envarsus to Limit Neurological… (NCT03263052) | Clinical Trial Compass
CompletedNot Applicable
Converting Elderly Kidney Transplant Recipients From Tacrolimus to Envarsus to Limit Neurological AE and Improve QOL
United States40 participantsStarted 2017-07-01
Plain-language summary
This study will investigate whether converting patients from FDA approved immediate-release tacrolimus to FDA approved extended release tacrolimus (Envarsus) reduces neurological side-effects, improves quality of life, and enhances adherence. A select group of elderly (\> 60 years of age) patients, who are especially sensitive to tacrolimus-related adverse (AEs) effects, will be provided the opportunity to convert to Envarsus with this study.
Who can participate
Age range60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The subject is a recipient of a living donor or deceased donor kidney only transplant
✓. Subject is \> 60 years of age
✓. Subject reports neurological AEs from tacrolimus that include one or more of the following: insomnia, vertigo, photophobia, mood disturbances, tremor, and/or headache.
✓. Patients must be able to understand English and provide written informed consent
✓. Patients receiving a stable dose (i.e., no dose adjustments) of immediate-release tacrolimus (Prograf) or extended-release tacrolimus (Astagraf) for a minimum of 4-7 days at screening
✓. Patients with a screening tacrolimus trough level of 3-12 ng/mL, measured between Day -7 to 0
✓. 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)
✓. Patients must be willing to commit to and comply with the schedule of study visits
Exclusion criteria
✕. Multi-organ transplant
✕. Subjects not taking tacrolimus post-transplant
✕. Documented Parkinson's disease or dementia
✕. Known cause of neurological symptoms other than tacrolimus
What they're measuring
1
Quality of life (QOL)
Timeframe: through study completion, an average of two years
2
Neurological Scores
Timeframe: through study completion, an average of two years
✕. Patients with significant visual and hearing impairments affecting their ability to complete the study requirements and assessments
✕. Patients with any severe medical condition (including infection) requiring acute or chronic treatment that in the Investigator's opinion would interfere with study participation
✕. Known non-adherence (defined as documentation in the patient chart of multiple missed visits and/or medication doses) which in the investigator's opinion would interfere with the objectives of the study
✕. Patients who are taking any acute or chronic medications that may impact reaction time, memory, or sleep habits, based on Investigator discretion