Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome: Open-label, Multi-center, Single Arm, Phase 4 Trial (DoSAKOM)

223KT17017

Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients

2018-03-31

2022-07-22

2023-04-27

Completed

Early phase I

169

Inclusion Criteria: 1. Over 19 years old(male or female) 2. Patients who are planning to receive a kidney from a deceased or a living unrelated/related donor 3. Agreement with written informed consent Exclusion Criteria: 1. Donor's HLA antigen matches recipient or the Degree of Mis-Match is 0 2. Patients with high sensitization who need desensitization therapy 3. Multi organ recipients or previous transplant with any organs 4. Diagnosed with cancer within five years 5. Patient who receive kidney from ABO incompatibility donor or Lymphocyte cross-match positive donor 6. Patients who have positive HIV, HBsAg or Anti-HCV test result 7. At screening * Under treatment for active liver disease, or Over 3times upper than normal range of liver function test (T-bilirubin, AST, ALT) * WBC\<2,500/mm3, PLT \<50,000/mm3, ANC\<1,500/mm3 8. Pregnant or lactating women 9. In investigator's judgment

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 169, 'type': 'ACTUAL'}}

2024-05-22