XR Tacrolimus for Heart Transplant Recipients

Recruiting in Palo Alto (17 mi)

Overseen bySanjeev Akkina, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Loyola University

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing Tacrolimus XR, a slow-release medication, in heart transplant recipients. The goal is to see if it reduces kidney damage by maintaining steady drug levels and avoiding high peaks. Researchers hope this will improve kidney function without harming the transplanted heart. Tacrolimus (FK 506) is a novel immunosuppressive agent that has been in clinical use for solid organ transplantation since 1989.

Research Team

Sanjeev Akkina, MD

Principal Investigator

Loyola University

Eligibility Criteria

This trial is for heart transplant recipients aged 18-80, within 10 years post-transplant, currently on IR Tacrolimus with stable function and a baseline kidney filtration rate (eGFR) over 30. It excludes those under 18 or over 80, with active cancer, recent rejection episodes, multiple organ transplants or more than a decade since their heart transplant.

Inclusion Criteria

I am currently on IR Tacrolimus medication.

Your kidney function, measured as eGFR, is higher than 30 mL/min/1.73m2.

I am between 18 and 80 years old.

See 1 more

Exclusion Criteria

I had a heart transplant over 10 years ago, or I have cancer or rejection issues post-transplant.

I am under 18 years old.

I have received transplants for more than one organ.

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Treatment Details

Interventions

Tacrolimus (Immunosuppressant)

Trial OverviewThe study tests the effects of switching from Immediate Release (IR) Tacrolimus to Extended Release (XR) Tacrolimus in heart transplant patients. The goal is to see if XR Tacrolimus causes less kidney tubular injury due to its lower peak levels but similar overall exposure as IR.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Extended Release TacrolimusExperimental Treatment1 Intervention

All participants who consent to the study will be in this group.

Tacrolimus is already approved in Canada, Japan, Switzerland for the following indications: