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This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A) TEST | Active Comparator |
| |
| B) CONTROL | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A) TEST | Drug |
After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level. |
| Measure | Description | Time Frame |
|---|---|---|
| Failure rate in effectiveness of up to 12 months after kidney transplant |
| 12 months after kidney transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook national hospital | Daegu | Daegu | South Korea | |||
| Ajou Univeristy Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28810721 | Derived | Huh KH, Lee JG, Ha J, Oh CK, Ju MK, Kim CD, Cho HR, Jung CW, Lim BJ, Kim YS; RECORD Study. De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial. Nephrol Dial Transplant. 2017 Aug 1;32(8):1415-1424. doi: 10.1093/ndt/gfx093. |
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|
|
| B) CONTROL | Drug |
|
|
|
| Suwon |
| KyungKi Province |
| South Korea |
| Severance hospital | Seoul | Seoul | 120-752 | South Korea |
| Gangnam Severance hospital | Seoul | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | Seoul | South Korea |
| Seoul National University hospital | Seoul | Seoul | South Korea |
| Ulsan Univ Hospital | Ulsan | Ulsan | South Korea |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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