What side effects are associated with this type of intervention?

Common treatments for heart transplant patients, such as Tacrolimus XR, which has delayed absorption and lower peak levels, are associated with several side effects. These include nephrotoxicity, which can lead to renal tubular injury, and the need for careful monitoring of renal function. Other side effects of calcineurin inhibitors like tacrolimus and cyclosporine include hypertension, hyperglycemia, and an increased risk of infections due to immunosuppression. Additionally, patients may experience gastrointestinal disturbances, tremors, and potential neurotoxicity. Regular monitoring and dose adjustments are essential to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved various formulations of tacrolimus for heart transplant patients, including immediate-release (IR) and extended-release (XR) versions. Tacrolimus XR, such as Envarsus, is designed for once-daily dosing with delayed absorption and lower peak levels compared to IR tacrolimus. This formulation aims to reduce renal tubular injury and improve renal function while maintaining similar efficacy and safety profiles. Other related drugs include cyclosporine, another calcineurin inhibitor used in transplant patients, though tacrolimus is often preferred due to its more favorable side effect profile.

What other types of research exist?

Promising novel alternatives to Tacrolimus XR for heart transplant patients include Belatacept, which has shown efficacy and safety in long-term studies, and Sirolimus, which has been associated with reduced malignancy risk and good outcomes in kidney transplant patients. Both agents offer different mechanisms of action and may provide benefits in terms of reduced nephrotoxicity and improved long-term outcomes.

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Immunosuppressant

XR Tacrolimus for Heart Transplant Recipients

Phase 4

Recruiting

Led By Sanjeev Akkina, MD

Research Sponsored by Loyola University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently taking IR Tacrolimus

18-80 years old

Must not have

Heart-only transplants recipients with active malignancy, rejection, or greater than 10 years from transplantation

Less than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, tacrolimus can generally cause side effects like tremors, high blood pressure, kidney problems, diabetes after transplantation and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I am currently on IR Tacrolimus medication.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am under 18 years old.

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I have received transplants for more than one organ.

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I am over 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Urinary neutrophil gelatinase-associated lipocalin (NGAL)

Secondary study objectives

Blood pressure

CYP3A5 expressor category

Cardiac allograft vasculopathy

+5 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Extended Release TacrolimusExperimental Treatment1 Intervention

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart transplant patients include immunosuppressive drugs like Tacrolimus, which inhibits T-lymphocyte activation by binding to the FK506-binding protein, thereby preventing organ rejection. Tacrolimus XR, with its delayed absorption and lower peak levels, aims to reduce renal toxicity and improve patient compliance by maintaining stable drug levels. This is crucial for heart transplant patients as it minimizes the risk of acute rejection and long-term complications, ensuring better graft survival and overall patient outcomes.