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A Study Of Follow Up On Patients Who Participated In The SIMPLE Study

Overview

About this study

The purpose of this study is to assess patient reported outcomes related to medication side effects > 1 year after kidney transplant and compare these results to those obtained in the early transplant period and to collect data on clinical parameters to assess kidney allograft function correlate this to reported outcomes at the same timepoint.

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:

  • Patients who completed surveys at baseline and 12 months post-transplant as a part of the SIMPLE study and sign a consent form to participate in the follow up survey and clinical data collection

  • The above patients all fell within the inclusion criteria of the original 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 who did not complete surveys at baseline and 12 months post-transplant as a part of the SIMPLE study

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

 

Eligibility last updated 009/09/2025. Questions regarding updates should be directed to the study team contact.

 

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.

Contact us for the latest status

Contact information:

Nong Yowe Braaten

5072666893

braaten.nong@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20598497

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