Once-Daily vs Twice-Daily Tacrolimus for Kidney Transplant Recipients

(SIMPLE Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Mark Stegall, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Patient is able to comply with study procedures for the entire length of the study.

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

Patient has been informed about the study survey and has signed an informed consent form.

Exclusion Criteria

Patient is in a setting where a professional care taker is responsible for dispensing subject's medication.

I am currently taking medication that includes sirolimus or everolimus.

I am currently taking azathioprine.

Participant Groups

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.

Group I: Envarsus XR Active Control 1 Intervention

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

Group II: Tacrolimus twice-daily Active Control 1 Intervention

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

Envarsus XR is already approved in United States for the following indications:

🇺🇸 Approved in United States as Envarsus XR for:

• Prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic Arizona Phoenix, AZ

Mayo Clinic Florida Jacksonville, FL

Mayo Clinic Rochester Rochester, MN

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

Veloxis Pharmaceuticals Industry Sponsor

References