Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-14

Study Completion Date

2030-12-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of lower dose calcineurin inhibitors (CNI) in combination with Everolimus in Korean heart transplant recipients.

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Detailed Description

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This study is a prospective, multicenter, open-label, randomized, comparative, phase 4 trial to optimize immunosuppressive therapy using everolimus and low-dose calcineurin inhibitors in heart transplant patients in Korea.

Conditions

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Heart Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Certirobell Tablet

Everolimus

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Up to 1.5g BID(total 3g daily), PO - Check the blood concentration of Everolimus at each visit

Myrept Tablet/Capsule

Mycophenolate mofetil

Group Type ACTIVE_COMPARATOR

Mycophenolate mofetil Tablet/Capsule

Intervention Type DRUG

Up to 1.5g BID(total 3g daily), PO

Interventions

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Everolimus

Up to 1.5g BID(total 3g daily), PO - Check the blood concentration of Everolimus at each visit

Intervention Type DRUG

Mycophenolate mofetil Tablet/Capsule

Up to 1.5g BID(total 3g daily), PO

Intervention Type DRUG

Other Intervention Names

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Certirobell Tablet Myrept® Cap./Tab.

Eligibility Criteria

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Inclusion Criteria

1. Over 19 years old
2. Patients with stable heart transplant graft function at least 28\~100 days post transplant.
3. Patients who are appropriate for combination therapy with Everolimus and Calcineurin inhibitor (CNI) at the investigator's discretion

Exclusion Criteria

1. Recipients who have had a prior organ transplant, or who underwent a heart transplant with the simultaneous transplantation of another organ.
2. Recipients of heart from ABO-incompatible donor
3. Recipients of heart from the donor aged 70 or older

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No