Efficacy and Safety of Sirolimus Plus CNI Compared With MMF Plus CNI in ABO-i Kidney Transplant Recipients.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.

Detailed Description
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This study is Multi-center, Open-label, Randomized Controlled Phase 4 Study to Evaluate the Efficacy and Safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.

Official Title
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Evaluate the Efficacy and Safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared With Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO Incompatible De Novo Living Kidney Transplant Recipients. [ART Study]

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Sirolimus Tab.
* Drug: Mycophenolate Mofetil Cap./Tab.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: [Time of Screening] Patients who plan to be transplanted ABO incompatible living donor kidney or not past 35 days after kidney transplantation More than the age of 19 years old Agreement with written informed consent [Time of Randomization] Patients who have transplanted Kidney within 4 weeks(25 days to 35 days) Patients who take CNI plus MMF after kidney transplantation Exclusion Criteria: [Time of Screening] Patients who have transplanted non-kidney organs or have plan to be transplanted non-kidney organs PRA > 50% before desenitization or positive results of DSA Receive a kidney from a related donor who showed HLA identical Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor Allergic/hypersensitivity reaction in the history of Investigational drugs or additives Women who are pregnant or breast feeding or not agree to the proper use of contraception during the trial Patient has conversation impairment because of mental illness within 6months Participated in other trial within 4 weeks In investigator's judgement [Time of Randomization] Patients with acute rejection who have been clinically treated after kidney transplantation At the time of Randomization 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 Patients who had plasmapheresis within 1 week Patents who had a record of taking mTOR inhibitor before In investigator's judgement

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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>ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant. | Drug: Sirolimus Tab.<br>* Orally, once-daily in the morning - The first dose is administered within maximum 6mg/day according to the investigator's judgement, check the blood concentration of Sirolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3 8ng/ml.<br>* Other names: RaparoBell® Tab.;|
| Active Comparator: Mycophenolate Mofetil Tablet/Capsule<br>ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant. | Drug: Mycophenolate Mofetil Cap./Tab.<br>* Up to 1g BID(total 2g daily), PO<br>* Other names: Myrept® Cap./Tab.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of composite efficacy failure | Composite efficacy failure include biopsy-confired acute rejection, graft loss, death, or follow-up failure | Until 48 weeks after taking medicine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of composite efficacy failure | Composite efficacy failure include biopsy-confired acute rejection, graft loss, death, or follow-up failure | Until 24 weeks after taking medicine | 
| Incidence of biopsy-confirmed acute rejection | Banff Criteria | Until 24weeks and 48weeks after taking medicine | 
| The pathological results and time of occurrence and method of treatment, result of the treatment of acute rejection confirmed by biopsy | Banff Criteria | Until 24weeks and 48weeks after taking medicine | 
| Survival rate | transplanted organ and patients | Until 24weeks and 48weeks after taking medicine | 
| Function of Kidney | eGFR using MDRD(Modification of Diet in Renal Disease) method | Until 24weeks and 48weeks after taking medicine | 
| Incidence of CMV, BKV infection | Incidence of CMV, BKV infection | Until 24weeks and 48weeks after taking medicine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplantation, ABO incompatible, Sirolimus