Envarsus XR Compared to Immediate Release Tacrolimus

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare once-daily tacrolimus extended-release (Envarsus XR®) to twice-daily immediate release tacrolimus to find out if people taking tacrolimus extended release (Envarsus XR®) report fewer side effects, increased medication compliance and higher scores on quality of life assessments compared to people taking twice daily tacrolimus immediate release.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Veloxis Pharmaceuticals
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Patient is an adult (18 years of age or older).

• Patient is a recipient of a deceased or living donor kidney transplant.

• Patient is able to comply with study procedures for the entire length of the study.

• Patient has been informed about the study survey and has signed an informed consent form.

Exclusion Criteria:

• Patient is unable or unwilling to complete study patient reported outcome questionnaires.

• Patient is currently receiving azathioprine

• Patient is currently receiving an mTOR inhibitor (sirolimus, everolimus)

• Patient is currently receiving an belatacept

• Patient has received investigational immunosuppression 1 month prior to transplant or post-transplant

• Patient is in a setting where a professional care taker is responsible for dispensing subject's medication.