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Envarsus XR Compared to Immediate Release Tacrolimus

NCT ID: NCT03979365

Last Updated: 2025-12-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-18

Study Completion Date

2022-03-29

Brief Summary

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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.

Detailed Description

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Despite improvement in short-term graft outcomes in organ transplant, transplant patients still have to take on complex medication regimens to achieve current results. Adherence to these complex medications is an important problem in light of the potential risk of acute and chronic rejection and the associated burden of increased hospitalization, cost, and diminished quality of life that results from missed doses and poor overall drug taking. Part of the diminished quality of life is also tied to the bothersome symptoms patient feel after transplant. Most patients experience symptoms that relate to either the overall transplant immunosuppression or medication specific side effects. In the BENEFIT and BENEFIT-EXT trials, \>60% of patients reported tiredness and lack of energy as an issue. Sleep problems, mood swings, restlessness, anxiety, depression, and concentration and memory difficulties appeared in approximately 50-60% of patients. In addition to these symptoms, \>38% patients also reported numerous others side effects that have been strongly associated with calcineurin-inhibitors such as tacrolimus that include dizziness, muscle cramps, trembling hands, tingling in hands and feet, and headache.

The investigators hypothesize that the use of once-daily Envarsus XR® could decrease some transplant- and tacrolimus-related adverse symptoms and potentially lead to improvement in quality of life and medication adherence when compared to twice-daily tacrolimus. In order to assess this hypothesis, a prospective, multi-center, randomized, open-label, pilot study to investigate medication adherence and patient reported symptom occurrence and interference with daily life comparing once-daily Envarsus XR® and twice-daily immediate release tacrolimus in adult renal transplant recipients (SIMPLE) is being proposed.

Conditions

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Kidney Transplant Recipients

Keywords

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tacrolimus envarsus xr renal transplant kidney transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Tacrolimus twice-daily

Subjects assigned to this arm will take tacrolimus two times daily by mouth, at the clinically prescribed dose.

Group Type ACTIVE_COMPARATOR

Tacrolimus twice daily

Intervention Type DRUG

Twice daily tacrolimus

Envarsus XR

Subjects assigned to this arm will take Envarsus XR one time daily by mouth, at the clinically prescribed dose.

Group Type ACTIVE_COMPARATOR

Envarsus XR

Intervention Type DRUG

Once daily Envarsus XR

Interventions

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Envarsus XR

Once daily Envarsus XR

Intervention Type DRUG

Tacrolimus twice daily

Twice daily tacrolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Veloxis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mark Stegall

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Stegall, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Arizona

Phoenix, Arizona, United States

Site Status

Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

Reference Type DERIVED
PMID: 36094829 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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19-002678

Identifier Type: -

Identifier Source: org_study_id