XR Tacrolimus for Heart Transplant Recipients

Overseen By Sanjeev Akkina, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Loyola University

Must be taking: IR Tacrolimus

Disqualifiers: Multiple organ transplants, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

42 Participants Needed

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 received a heart transplant within the last 10 years and my condition is stable.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are converted from immediate release tacrolimus to extended release tacrolimus and monitored for changes in urinary biomarkers of tubular injury

4 weeks

1 visit (in-person) for conversion and monitoring

Follow-up

Participants are monitored for changes in cardiac function, blood pressure, serum glucose, and cholesterol levels

1 year

Regular visits (in-person) for monitoring

Treatment Details

Interventions

• Tacrolimus

Trial Overview The 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

Group I: Extended Release Tacrolimus Experimental Treatment 1 Intervention

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

Tacrolimus is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Prograf for:

• Prevention of organ rejection in liver, kidney, and heart transplant patients

Approved in United States as Prograf for:

• Prevention of organ rejection in liver, kidney, and heart transplant patients

Approved in Canada as Advagraf for:

• Prevention of organ rejection in liver, kidney, and heart transplant patients

Approved in Japan as Prograf for:

• Prevention of organ rejection in liver, kidney, and heart transplant patients

Approved in Switzerland as Prograf for:

• Prevention of organ rejection in liver, kidney, and heart transplant patients

Who Is Running the Clinical Trial?

Loyola University

Lead Sponsor

Trials

161

Recruited

31,400+

Veloxis Pharmaceuticals

Industry Sponsor

Trials

43

Recruited

3,200+