Status:
COMPLETED
Converting Elderly Kidney Transplant Recipients From Tacrolimus to Envarsus to Limit Neurological AE and Improve QOL
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Disorder Related to Renal Transplantation
Eligibility:
All Genders
60+ years
Brief 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, improve...
Detailed Description
Tacrolimus (Prograf) is a calcineurin inhibitor that is widely used in all types of solid organ transplants. However, one of the major limitations in using tacrolimus are the adverse effects that sign...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03263052
Start Date
July 1 2017
End Date
January 1 2020
Last Update
April 22 2020
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612