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Envarsus XR Compared to Immediate Release Tacrolimus

NCT03979365 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2025-12-18

Study results available
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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

Interventions

DRUG

Envarsus XR

Once daily Envarsus XR

DRUG

Tacrolimus twice daily

Twice daily tacrolimus

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Mark Stegall, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-18
Primary Completion
2022-03-29
Completion
2022-03-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03979365 on ClinicalTrials.gov