MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients (MyMy)

Chong Kun Dang

Status and phase: Enrolling; Phase 4

Conditions: Kidney Transplant

Treatments: Drug: Myreptic-N Tablet; Drug: Mycophenolate mofetil Tablet/Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT06044493

B130_01KT2203

Details and patient eligibility

About

The purpose of this study is to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients after Kidney Transplant Recipients

Full description

This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety of MYREPTIC-N® or MY-REPT® administration for 24 weeks in renal transplant patients combined Calcineurin inhibitor.

Enrollment: 158 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Over 19 years old
2. Patients who at least 1 year after kidney transplant
3. serum creatinine ≤2.3 mg/dL
4. Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolate Mofetil after kidney transplantation

Exclusion criteria

1. Patients who had received treatment Acute rejection within 4 weeks

2. Patients who had discontinued corticosteroid within 4 weeks

3. At the time of Screening

   • Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
   • WBC< 2,500/mm^3, or platelet < 75,000/mm^3, or ANC < 1,300/ mm^3

4. In investigator's judgement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Myreptic-N Tablet

Experimental group

Description:

Mycophenolate sodium

Treatment:

Drug: Myreptic-N Tablet

Myrept Tablet/Capsule

Active Comparator group

Description:

Mycophenolate mofetil

Treatment:

Drug: Mycophenolate mofetil Tablet/Capsule