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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 Stable Renal Transplant Receiving Tacrolimus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171392
First Posted: September 15, 2005
Last Update Posted: February 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant patients.

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 in Patients With Stable Renal Transplant Receiving Tacrolimus

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: 132
Study Start Date: March 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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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/kidney-pancreas transplant received at least six months previously;
  • Immunosuppressive therapy with tacrolimus and mycophenolate mofetil (MMF);

Exclusion Criteria:

Subjects expected to discontinue tacrolimus 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
Information from the National Library of Medicine

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): NCT00171392


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

Responsible Party: Novartis External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00171392     History of Changes
Other Study ID Numbers: CERL080AIT02
First Submitted: September 12, 2005
First Posted: September 15, 2005
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, tacrolimus.

Additional relevant MeSH terms:
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents