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Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped. For the others MMF remained at initial dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Tacrolimus/MMF/steroids throughout the study |
|
| 2 | Experimental | Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and seriousness of adverse events | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno | Czechia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17291216 | Background | Sulowicz W, Bachleda P, Rydzewski A, Rutkowski B, Szakaly P, Asztalos L, Samlik J, Lackova E, Ksiazek A, Studenik P, Mysliwiec M, Hruby Z, Navratil P, Gumprecht J. Discontinuation of mycophenolate mofetil from a tacrolimus-based triple regimen 2 months after renal transplantation: a comparative randomized, multicentre study. Transpl Int. 2007 Mar;20(3):230-7. doi: 10.1111/j.1432-2277.2006.00421.x. |
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| Mycophenolate Mofetil | Drug | oral |
|
|
| methylprednisolone and prednisone | Drug | IV and oral |
|
|
| Hradec Králové |
| Czechia |
| Olomouc | Czechia |
| Ostrava | Czechia |
| Debrecen | Hungary |
| Pécs | Hungary |
| Bialystok | Poland |
| Gdansk | Poland |
| Krakow | Poland |
| Lublin | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| Zabrze | Poland |
| Banska | Slovakia |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D008775 | Methylprednisolone |
| D011241 | Prednisone |
| D013256 | Steroids |
| 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 |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
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