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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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: September 12, 2005
Last updated: February 1, 2011
Last verified: February 2011
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 Intervention Phase
Prevention of Acute Rejection After Kidney Transplantation Drug: Enteric-Coated Mycophenolate Sodium Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula

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

Enrollment: 162
Study Start Date: March 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)

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

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.
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Please refer to this study by its identifier: NCT00171379

Sponsors and Collaborators
Study Director: Novartis Novartis
  More Information

Responsible Party: Novartis External Affairs, Novartis Pharmaceuticals Identifier: NCT00171379     History of Changes
Other Study ID Numbers: CERL080AIT01
Study First Received: September 12, 2005
Last Updated: February 1, 2011

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

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017