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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate mofetil | Experimental | One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate mofetil 500mg Tab. or 250mg Cap. | Drug | - Orally, up to 1g BID(total 2g daily) |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
Pregnant or lactating women
In investigator's judgment
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Kwan Oh, Ph.D | Ajou University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Suwan | South Korea |
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| Tacrolimus | Drug | - Orally, check the blood ceocentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3-8ng/ml |
|
| Methylprednisolone/prednisolone | Drug | - Methyprednisolone 500mg / Prednisolone 5mg |
|
| Basiliximab | Drug | - IV, 20mg(before Kidney transplat) / 20mg(Day 4 of kidney transplant) |
|
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D013607 | Tablets |
| D002214 | Capsules |
| D016559 | Tacrolimus |
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D000077552 | Basiliximab |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D018942 | Macrolides |
| D007783 | Lactones |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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