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The patients about to undergo kidney transplantation will be randomized to one of the following two group:
Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | In combination with MMF and steroids |
|
| 2 | Active Comparator | In combination with MMF and steroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FK506MR | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Event rate of patients with acute rejections | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of and time to acute rejections | 12 Weeks | |
| Overall frequency of acute rejections | 12 Weeks | |
| Rate of patient and graft survival following transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Ao Jianhua | Department of Urologic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3 Sites | Beijing | Beijing Municipality | China | |||
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| Prograf | Drug | oral |
|
|
| Mycophenolate Mofetil | Drug | oral |
|
|
| Methylprednisolone | Drug | oral |
|
| Prednisolone | Drug | oral |
|
| 12 Weeks |
| Fuzhou |
| Fujian |
| China |
| 2 Sites | Guangzhou | Guangdong | China |
| Wuhan | Hubei | China |
| Changsha | Hunan | China |
| Shenyang | Liaoning | China |
| 2 Sites | Shanghai | Shanghai Municipality | China |
| Chongqing | Sichuan | China |
| Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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