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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RaparoBell® Tablet | Experimental | ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant. |
|
| Mycophenolate Mofetil Tablet/Capsule | Active Comparator | ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus Tab. | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
[Time of Screening]
[Time of Randomization]
Exclusion Criteria:
[Time of Screening]
[Time of Randomization]
Patients with acute rejection who have been clinically treated after kidney transplantation
At the time of Randomization
Patients who had plasmapheresis within 1 week
Patents who had a record of taking mTOR inhibitor before
In investigator's judgement
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyu Ha Huh, M.D, Ph.D | Contact | +82-2-2228-2138 | KHHUH@yuhs.ac | |
| Jung A Lee | Contact | +82-2-2194-0403 | junaa82@ckdpharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Kyu Ha Huh, M.D, Ph.D | Severance Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Mycophenolate Mofetil Cap./Tab. | Drug | Up to 1g BID(total 2g daily), PO |
|
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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 |