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The purpose of this study is to evaluate the safety and the tolerability of the substitution of mycophenolate mofetil for enteric-coated mycophenolate sodium in a population of stable renal transplant patients in Brazil, in a treatment regimen of immunosuppressants with tacrolimus and mycophenolate mofetil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Mycophenolate sodium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate sodium | Drug | Mycophenolate sodium |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms in renal transplant patients treated with the immunosuppression regimen of tacrolimus and mycophenolate at baseline, 8 and 16 weeks | 8 and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of gastrointestinal symptoms on quality of life. Tolerability of mycophenolate sodium in combination with tacrolimus assessed by OSRS. Safety of mycophenolate sodium in combination with tacrolimus assessed by incidence of adverse events | 8 and 16 weeks |
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Inclusion criteria
Exclusion criteria History of acute rejection,
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26398638 | Result | Pacheco e Silva Filho A, Manfro RC, Contieri FL, Mazzali M, Garcia VD, Carvalho Dde B, David S, Machado P, Rodrigues CA. Evaluation of tolerability of enteric-coated mycophenolate sodium versus mycophenolate mofetil in de novo renal transplantation. J Bras Nefrol. 2015 Jul-Sep;37(3):291-6. doi: 10.5935/0101-2800.20150048. English, Portuguese. |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| D005227 |
| Fatty Acids |
| D008055 | Lipids |