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

Chong Kun Dang

Status and phase: Begins enrollment in 2 months; Phase 4

Conditions: Heart Transplant

Treatments: Drug: Everolimus; Drug: Mycophenolate mofetil Tablet/Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT06942156

B95_05HTx2501

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Certirobell Tablet

Experimental group

Description:

Everolimus

Treatment:

Drug: Everolimus

Myrept Tablet/Capsule

Active Comparator group

Description:

Mycophenolate mofetil

Treatment:

Drug: Mycophenolate mofetil Tablet/Capsule