A Study to Evaluate the Safety and Effectiveness of Once-Daily Envarsus XR® and Twice-Daily, Immediate-Release Tacrolimus in Adult Renal Transplant Recipients

Overview

About this study

The purpose of this study is to compare tacrolimus formulations (Envarsus XR® versus twice a day tacrolimus) with the hypothesis that Envarsus XR® improves transplant- and tacrolimus- associated symptoms when compared to a twice a day tacrolimus regimen.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  • Patient is an adult (18 years of age or older).
  • Treatment with Envarsus XR® or immediate-release, twice-daily tacrolimus has been indicated by patient’s transplant care team. 
  • 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:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • 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 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Open for enrollment

Contact information:

Nong Braaten L.P.N.

Braaten.Nong@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Martin Mai, M.D.

Open for enrollment

Contact information:

Joel Espinoza B.S.

Espinoza.Joel@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Sumi Sukumaran Nair, M.B.B.S., M.D.

Open for enrollment

Contact information:

Angela Eyshou M.B.A.

(480) 342-6536

Eyshou.Angela@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20491456

Mayo Clinic Footer