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

NCT03263052 | Completed FDA Drug

• 1 other identifier: 2017-0400
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Disorder Related to Renal Transplantation

Keywords

kidney transplant; immunosuppression; tacrolimus XR; elderly; quality of life; neurological adverse events

Outcome Measures

Primary Outcomes (2)

• Quality of life (QOL)

  Mean change in QOL scores from baseline to day 14 and day 28 after conversion from tacrolimus to Envarsus.

  through study completion, an average of two years

• Neurological Scores

  Mean change in neurological scores (including insomnia, vertigo, photophobia, mood, headache, and tremor) from baseline to day 14 and day 28 after conversion from tacrolimus to Envarsus.

  through study completion, an average of two years

Secondary Outcomes (3)

• Tacrolimus preference

  through study completion, an average of two years

• Non-adherence

  through study completion, an average of two years

• Incremental costs

  through study completion, an average of two years

Study Arms (1)

Tacrolimus XR

Drug: Tacrolimus XR (Envarsus)

Interventions

Tacrolimus XR (Envarsus) DRUG

Elderly patients (age 60 or older) on tacrolimus experiencing neurological AEs (tremor, insomnia, vertigo, photophobia, mood disturbances, or headache) presumably from tacrolimus immediate-release or tacrolimus XL will be converted to Envarsus. This conversion will be based on the Envarsus package insert which is a 20% reduction in total daily dose and is taken once a day. The conversion from Astagraf to Envarsus will be a 36% reduction.

Tacrolimus XR

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll elderly kidney transplant recipients who are at least 60 years of age and have experienced neurological adverse events while on generic tacrolimus, Prograf, or Astagraf XL.

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Veloxis Pharmaceuticals: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 28, 2017
• Study Start: July 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)