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The purpose of this study is to evaluate the efficacy and Safety after conversion to RaparoBell® or Myrept® in patients who in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.
This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to RaparoBell® or Myrept® administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RaparoBell Tablet | Experimental | RaparoBell Tablet |
|
| Mycophenolate Mofetil Tablet/Capsule | Active Comparator | Myrept Tablet/Capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus | Drug | Orally, once-daily in the morning - Check the blood concentration of Sirolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~8ng/mL |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of composite efficacy failure | Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure | Until 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biopsy-confirmed acute rejection(TCMR, AMR) | The frequency and Incidence | Until 24 weeks |
| Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have transplanted organs other than kidney
At the time of Screening
Patents who had a record of taking mTOR inhibitor before 3 months
In investigator's judgement
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| Name | Affiliation | Role |
|---|---|---|
| Jae Berm Park, Ph.D | Samsung Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, South Korea | Seoul | South Korea |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 |
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|
| Mycophenolate mofetil | Drug | Up to 1g BID(total 2g daily), PO |
|
|
By Banff classification categories
| Until 24 weeks |
| Survival rate of transplanted organ | Kaplan-Meier | Until 24 weeks |
| Survival rate of Patients | Kaplan-Meier | Until 24 weeks |
| Serum-Cr, eGFR | eGFR using MDRD | Until 24 weeks |
| Incidence of BKV, CMV infection | The frequency and Incidence | Until 24 weeks |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |