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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171392
First received: September 12, 2005
Last updated: February 1, 2011
Last verified: February 2011

September 12, 2005
February 1, 2011
March 2004
June 2005   (final data collection date for primary outcome measure)
Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula
Not Provided
Complete list of historical versions of study NCT00171392 on ClinicalTrials.gov Archive Site
  • 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)
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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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Prevention of Acute Rejection After Kidney Transplantation
Drug: Enteric-coated mycophenolate sodium
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
June 2005
June 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
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NCT00171392
CERL080AIT02
Not Provided
Novartis External Affairs, Novartis Pharmaceuticals
Novartis
Not Provided
Study Director: Novartis Novartis
Novartis
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP