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To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | steroid regimen 1 |
|
| 2 | Experimental | steroid regimen 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and time to first biopsy-proven acute rejection | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall frequency of acute rejection episodes within 6 months post transplantation | 6 months | |
| Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | ZAO Astellas Pharma Russia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow | 115446 | Russia | ||||
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| Mycophenolate Mofetil | Drug | oral |
|
|
| Methylprednisolone or equivalent | Drug | oral |
|
| Prednisone | Drug | oral |
|
| Incidence of and time to first corticosteroid-resistant acute rejection | 6 months |
| Subject and graft survival | 6 months |
| Moscow |
| 119992 |
| Russia |
| Moscow | 123182 | Russia |
| Omsk | 644112 | Russia |
| Saint Petersburg | 197110 | Russia |
| Volzskii | 404120 | Russia |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D008775 | Methylprednisolone |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
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