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Calcineurin Inhibitor

Once-Daily vs Twice-Daily Tacrolimus for Kidney Transplant Recipients (SIMPLE Trial)

Phase 4
Waitlist Available
Led By Mark Stegall, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is a recipient of a deceased or living donor kidney transplant.
Patient is an adult (18 years of age or older).
Must not have
Patient is currently receiving an mTOR inhibitor (sirolimus, everolimus)
Patient is currently receiving azathioprine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 4 to 12 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial is testing whether a once-daily tacrolimus pill causes fewer side effects and is more convenient than the twice-daily tacrolimus pill, and whether patients' quality of life is better on the once-daily pill.

Who is the study for?
Adult kidney transplant recipients who can follow the study's procedures and have signed a consent form are eligible. Those on belatacept, azathioprine, mTOR inhibitors like sirolimus or everolimus, or with professional caretakers handling their meds cannot join.
What is being tested?
The trial is testing if once-daily Envarsus XR (extended-release tacrolimus) leads to fewer side effects and better quality of life compared to twice-daily immediate release tacrolimus in kidney transplant patients.
What are the potential side effects?
Potential side effects for both forms of tacrolimus may include tremors, high blood pressure, kidney problems, diabetes after transplantation, diarrhea, and an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have received a kidney transplant from a living or deceased donor.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication that includes sirolimus or everolimus.
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I am currently taking azathioprine.
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I am currently taking belatacept.
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I am unable or unwilling to fill out study questionnaires.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 4 to 12 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 4 to 12 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tacrolimus
Secondary study objectives
Adverse events
Change in any one calcineurin inhibitor-related symptom
Change in calcineurin inhibitor-related symptoms as measured by a change in the Calcineurin Inhibitor-Related Symptoms (CIRC) severity score.
+9 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: Envarsus XRActive Control1 Intervention
Subjects assigned to this arm will take Envarsus XR one time daily by mouth, at the clinically prescribed dose.
Group II: Tacrolimus twice-dailyActive Control1 Intervention
Subjects assigned to this arm will take tacrolimus two times daily by mouth, at the clinically prescribed dose.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,060,779 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
2,830 Total Patients Enrolled
Mark Stegall, M.D.Principal Investigator - Mayo Clinic
Mayo Clinic Hospital-Rochester Saint Marys Campus
Columbia University College Of Physicians And Surgeons (Medical School)
University Of Wi Hosp & Cli (Residency)

Media Library

Envarsus XR (Calcineurin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03979365 — Phase 4
Kidney Transplant Recipients Research Study Groups: Envarsus XR, Tacrolimus twice-daily
Kidney Transplant Recipients Clinical Trial 2023: Envarsus XR Highlights & Side Effects. Trial Name: NCT03979365 — Phase 4
Envarsus XR (Calcineurin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03979365 — Phase 4
~20 spots leftby Jul 2025
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