A Multicenter, Randomization, Open-label Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients

B130_01KT2203

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

2023-11-01

2025-09-01

2025-11-01

Not yet recruiting

Early phase I

158

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 158, 'type': 'ESTIMATED'}}

2023-10-26