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The purpose of this study is to evaluate the efficacy and Safety after conversion to TacroBell SR cap. or TacroBell cap. in patients who in renal transplant patients undergoing maintenance therapy with Reference Tacrolimus.
This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to TacroBell SR cap. or TacroBell cap. administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Reference Tacrolimus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once-Daily Tacrolimus | Experimental | Experimental arm: TacroBell SR Cap. |
|
| Twice a Day Tacrolimus | Active Comparator | Active Comparator arm: TacroBell Cap. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TacroBell SR cap. | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure) | until 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biopsy-confirmed acute rejection(TCMR, AMR) | until 24 weeks | |
| Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy | until 24 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chul Woo Yang, Ph.D | Contact | 82-2-2258-6037 | yangch@catholic.ac.kr | |
| Jae Ri Bae | Contact | 82-2-2194-0468 | jaeri@ckdpharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Seoul, St.Mary's Hospital. | Recruiting | Seoul | South Korea |
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|
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| Tacrolimus cap. | Drug |
|
|
| Survival rate of transplanted organ |
| until 24 weeks |
| Survival rate of Patients | until 24 weeks |
| Serum-Cr value | until 24 weeks |
| eGFR(eGFR using CKD-EPI method) value | until 24 weeks |