Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium After Equimolar Conversion From Mycophenolate Mofetil (MMF) in Patients With Renal Transplant
NCT ID: NCT00171379
Last Updated: 2011-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
162 participants
INTERVENTIONAL
2004-03-31
2005-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Interventions
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Enteric-Coated Mycophenolate Sodium
Eligibility Criteria
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Inclusion Criteria
* Immunosuppressive therapy with cyclosporin and mycophenolate mofetil (MMF);
* Receiving an MMF dose of \<2/g/day because of any adverse event and/or altered laboratory test result attributed to MMF
Exclusion Criteria
* Patients with thrombocytopenia (\<75,000/mm3), an absolute neutrophil count of \<1,500/mm3 and/or leukopenia (\<2,500/mm3), or anemia (hemoglobin \<6 g/dl) at baseline;
* Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia \>2.5 mg/dL) or worsening renal function in the previous two months.
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis
Role: STUDY_DIRECTOR
Novartis
Other Identifiers
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CERL080AIT01
Identifier Type: -
Identifier Source: org_study_id
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