Envarsus XR Compared to Immediate Release Tacrolimus

NCT03979365 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19-002678
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Kidney Transplant Recipients

Keywords

tacrolimus; envarsus xr; renal transplant; kidney transplant

Outcome Measures

Primary Outcomes (1)

• Mean Change in Calcineurin Inhibitor-related Symptoms Severity Score

  The CIRS is a questionnaire that assesses five symptoms (from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events \[PRO-CTCAE\]) that have been shown to be associated with calcineurin inhibitors. These symptoms include trembling hands, muscle cramps, muscle weakness, swollen gums, and increased hair growth. Each symptom is based on symptom severity in the last 7 days scaled from 0 (none) - 4 (very severe). The cumulative score ranges from 0-20, with higher scores indicating a worse outcome.

  Baseline; 12 months

Secondary Outcomes (12)

• Change in the Severity Score in Each of the Five Individual CIRS Items

  Baseline; 12 months

• Number of Subjects With a Moderately Severe, Severe or Very Severe Score on Any CIRS Item

  12 months

• Change in the Number of Subjects Who Had a Reduction in Severity of Calcineurin Inhibitor-related Symptoms

  4 months; 12 months

• Change in the Number of Subjects Who Had at Least One Calcineurin Inhibitor-related Symptom Reduced by 1 Point or Greater

  4 months; 12 months.

• Transplant-related Symptoms as Measured by the Difference in Mean Transplant-related Symptoms (TRS) Score.

  Baseline; 12 months

Study Arms (2)

Tacrolimus twice-daily

ACTIVE COMPARATOR

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

Drug: Tacrolimus twice daily

Envarsus XR

ACTIVE COMPARATOR

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

Drug: Envarsus XR

Interventions

Envarsus XR DRUG

Once daily Envarsus XR

Envarsus XR

Tacrolimus twice daily DRUG

Twice daily tacrolimus

Tacrolimus twice-daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Veloxis Pharmaceuticals: collaborator

Study Sites (3)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 36094829 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Mark Stegall, M.D.
• Organization: Mayo Clinic

stegall.mark@mayo.edu

507-266-4505

Study Officials

• Mark Stegall, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 7, 2019
• Study Start: July 18, 2019
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: December 18, 2025
• Results First Posted: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)