Converting Elderly Kidney Transplant Recipients From Tacrolimus to Envarsus to Limit Neurological AE and Improve QOL

Completed

Conditions studied: Disorder Related to Renal Transplantation

In brief

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.

Key facts

Study ID

NCT03263052

Run by

University of Illinois at Chicago

People needed

40

Starts

2017-07-01

Expected to finish

2020-01-01

Last updated by the study team

2020-04-22

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Multi-organ transplant
• Subjects not taking tacrolimus post-transplant
• Documented Parkinson's disease or dementia
• Known cause of neurological symptoms other than tacrolimus
• 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
• Patients with any form of current drug or alcohol abuse as assessed by the Investigator

Where it is running

• University of Illinois at Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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