Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Multi-center, Open-label, Randomized Controlled Phase 4 Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients Undergoing Maintenance Therapy With CNI Plus MPA.[CORAL Study]

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Sirolimus
* Drug: Mycophenolate mofetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who at least 1 year and less than 10 years after kidney transplantation Over 20 years old Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation Exclusion Criteria: Patients who have transplanted organs other than kidney 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 Protein/Creatinine ratio≥1.0(mg/mg) Patents who had a record of taking mTOR inhibitor before 3 months In investigator's judgement

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RaparoBell Tablet<br>RaparoBell Tablet | Drug: Sirolimus<br>* 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<br>* Other names: RaparoBell® Tab.;|
| Active Comparator: Mycophenolate Mofetil Tablet/Capsule<br>Myrept Tablet/Capsule | Drug: Mycophenolate mofetil<br>* Up to 1g BID(total 2g daily), PO<br>* Other names: Myrept® Cap./Tab.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Transplantation, Sirolimus