Status:
NOT_YET_RECRUITING
Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Heart Transplant
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
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.
Detailed 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 transpl...
Eligibility Criteria
Inclusion
- Over 19 years old
- Patients with stable heart transplant graft function at least 28\~100 days post transplant.
- Patients who are appropriate for combination therapy with Everolimus and Calcineurin inhibitor (CNI) at the investigator's discretion
Exclusion
- Recipients who have had a prior organ transplant, or who underwent a heart transplant with the simultaneous transplantation of another organ.
- Recipients of heart from ABO-incompatible donor
- Recipients of heart from the donor aged 70 or older
Key Trial Info
Start Date :
August 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06942156
Start Date
August 14 2025
End Date
December 1 2030
Last Update
April 24 2025
Active Locations (1)
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1
Samsung Medical Center
Seoul, Seoul, South Korea, 06351