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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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 4 to 12 months

Awards & highlights

SIMPLE Trial 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.Check my eligibility

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.See study design

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.

SIMPLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have received a kidney transplant from a living or deceased donor.

Select...

I am 18 years old or older.

SIMPLE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 4 to 12 months.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tacrolimus

Secondary outcome measures

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

SIMPLE 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,766,620 Total Patients Enrolled

Veloxis PharmaceuticalsIndustry Sponsor

41 Previous Clinical Trials

2,906 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any additional investigations surrounding the twice-daily use of Tacrolimus?

"Currently, 150 active trials are investigating the efficacy of Tacrolimus twice-daily with 18 studies in Phase 3. Despite the prevalence of these experiments occurring in Nashville, Tennessee, 871 locations across the world have been hosting clinical research for this drug."

Answered by AI

What medical conditions is Tacrolimus twice-daily typically used to manage?

"Tacrolimus twice-daily is often recommended to patients with atopic dermatitis, as well other conditions like liver and kidney transplant rejection, and psoriasis."

Answered by AI

Is there any danger associated with a bifurcated dosage of Tacrolimus?

"Tacrolimus twice-daily scored a 3 on our safety scale as this treatment is already approved and in its fourth phase of clinical trials."

Answered by AI

What is the maximum number of participants eligible for this clinical experiment?

"Unfortunately, this clinical trial has ceased recruiting at the moment. Initially posted on July 18th 2019 and last updated on November third 2022, it is no longer taking in patients. However, if you're still looking for studies to join there are 15 trials that admit renal transplant recipients and 150 research projects assessing Tacrolimus twice-daily searching for test subjects."

Answered by AI

Are there any vacancies available to participants in this clinical investigation?

"This research trial is no longer recruiting, with the initial posting taking place on July 18th 2019 and a final update occurring November 3rd 2022. If you are still searching for trials to join, there are 15 actively enrolling renal transplant recipients and 150 studies looking at Tacrolimus in twice-daily doses."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Envarsus XR Compared to Immediate Release Tacrolimus

Mark Stegall 2019. "Envarsus XR Compared to Immediate Release Tacrolimus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03979365.

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