Kidney Transplant
Conditions
Keywords
Kidney transplant, Mycophenolic acid
Brief summary
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
Detailed description
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.
Interventions
DRUGMyreptic-N Tablet
Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit
Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over 19 years old 2. Patients who at least 1 year after kidney transplant 3. serum creatinine ≤2.3 mg/dL 4. Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolate Mofetil after kidney transplantation
Exclusion criteria
1. Patients who had received treatment Acute rejection within 4 weeks 2. Patients who had discontinued corticosteroid within 4 weeks 3. At the time of Screening * Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit * WBC\< 2,500/mm\^3, or platelet \< 75,000/mm\^3, or ANC \< 1,300/ mm\^3 4. In investigator's judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of composite efficacy failure | Until 24 weeks | Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in survey evaluation score [Gastrointestinal symptom rating scale(GSRS), EuroQol-5D(EQ-5D)] | Changes in scores from the baseline at week 24 | 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. |
| Intra patient variability of mycophenolic acid | Until 24 weeks | Measurement of blood levels of mycophenolic acid |
| Intra patient variability of calcineurin inhibitor | Until 24 weeks | Measurement of blood levels of calcineurin inhibitor |
| Incidence of Virus infection | Until 24 weeks | Frequency of incidence (BK Virus, CMV) |
| Incidence of biopsy-confirmed acute rejection | Until 24 weeks | Frequency of incidence |
| Incidence of Graft loss | Until 24 weeks | Frequency of incidence |
| Incidence of Death | Until 24 weeks | Frequency of incidence |
Countries
South Korea
Contacts
STUDY_CHAIRJongwon Ha, MD, PhD
Seoul National University Hospital
Outcome results
None listed