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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
This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety of MYREPTIC-N® or MY-REPT® administration for 24 weeks in renal transplant patients combined Calcineurin inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myreptic-N Tablet | Experimental | Mycophenolate sodium |
|
| Myrept Tablet/Capsule | Active Comparator | Mycophenolate mofetil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myreptic-N Tablet | Drug | Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit |
|
| 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 |
|---|---|---|
| Change in survey evaluation score [Gastrointestinal symptom rating scale(GSRS), EuroQol-5D(EQ-5D)] | The GSRS consists of 15 questions, with a total score of 15 to 105, indicating that the higher the total score, the more severe the gastrointestinal symptoms. The EQ-5D evaluates quality of life and consists of 5 questions. Each question is evaluated in the range of 1 to 5. The score is calculated according to EQ-5D index. Calculated score is lower that means poor health. |
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Inclusion Criteria:
Exclusion Criteria:
Patients who had received treatment Acute rejection within 4 weeks
Patients who had discontinued corticosteroid within 4 weeks
At the time of Screening
In investigator's judgement
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| Name | Affiliation | Role |
|---|---|---|
| Jongwon Ha, MD, PhD | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Mycophenolate mofetil Tablet/Capsule | Drug | Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit |
|
|
| Changes in scores from the baseline at week 24 |
| Intra patient variability of mycophenolic acid | Measurement of blood levels of mycophenolic acid | Until 24 weeks |
| Intra patient variability of calcineurin inhibitor | Measurement of blood levels of calcineurin inhibitor | Until 24 weeks |
| Incidence of Virus infection | Frequency of incidence (BK Virus, CMV) | Until 24 weeks |
| Incidence of biopsy-confirmed acute rejection | Frequency of incidence | Until 24 weeks |
| Incidence of Graft loss | Frequency of incidence | Until 24 weeks |
| Incidence of Death | Frequency of incidence | Until 24 weeks |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |