Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome

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

Detailed Description
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This study is a multi-center, non-comparative and phase IV clinical trial that evaluates incidence of Donor-Specific Antibody for 36 months after kidney transplantation when administered with Tacrolimus, Mycophenolate mofetil, and corticosteroid

Official Title
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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)

Conditions
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Kidney Transplant

Intervention / Treatment
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* Drug: Mycophenolate mofetil 500mg Tab. or 250mg Cap.
* Drug: Tacrolimus
* Drug: Methylprednisolone/prednisolone
* Drug: Basiliximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 19 years old(male or female) Patients who are planning to receive a kidney from a deceased or a living unrelated/related donor Agreement with written informed consent Exclusion Criteria: Donor's HLA antigen matches recipient or the Degree of Mis-Match is 0 Patients with high sensitization who need desensitization therapy Multi organ recipients or previous transplant with any organs Diagnosed with cancer within five years Patient who receive kidney from ABO incompatibility donor or Lymphocyte cross-match positive donor Patients who have positive HIV, HBsAg or Anti-HCV test result 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 Pregnant or lactating women In investigator's judgment

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mycophenolate mofetil<br>One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap. | Drug: Mycophenolate mofetil 500mg Tab. or 250mg Cap.<br>* - Orally, up to 1g BID(total 2g daily)<br>* Other names: Myrept® Cap./Tab.;Drug: Tacrolimus<br>* - Orally, check the blood ceocentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3-8ng/ml<br>Drug: Methylprednisolone/prednisolone<br>* - Methyprednisolone 500mg / Prednisolone 5mg<br>Drug: Basiliximab<br>* - IV, 20mg(before Kidney transplat) / 20mg(Day 4 of kidney transplant)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DSA(Donor-specific Anti-HLA Antibody) | Incidence of DSA(Donor-specific Anti-HLA Antibody) up to 36months after Kidney transplantation | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of composite efficacy failure | The frequency and percentage of composite efficacy failure (Treated-BPAMR & ACR, graft loss, death and follow-up loss) | 12, 24, 36months |