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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

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ClinicalTrials.gov Identifier: NCT00171379
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 2, 2011
Sponsor:
Information provided by:
Novartis

Study Description
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Brief Summary:
The aim of the study is to evaluate the safety and efficacy of equimolar conversion from MMF to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine.

Condition or disease Intervention/treatment Phase
Prevention of Acute Rejection After Kidney Transplantation Drug: Enteric-Coated Mycophenolate Sodium Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open-label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Patients With Renal Transplant
Study Start Date : March 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula

Secondary Outcome Measures :
  1. Incidence of biopsy proven acute rejection
  2. Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)
  3. Quality of life related to GI symptoms (GIQLI scale)
  4. Full blood count
  5. Gastrointestinal Adverse Events (check-list)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • First or second (single or double) deceased or living donor kidney transplant received at least six months previously;

    • 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:

  • • Subjects expected to discontinue cyclosporin therapy;

    • 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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171379


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Novartis External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00171379     History of Changes
Other Study ID Numbers: CERL080AIT01
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 2, 2011
Last Verified: February 2011

Keywords provided by Novartis:
Kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium.

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
 Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action