A Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: October 12, 2005
Last updated: November 1, 2011
Last verified: November 2011
The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||A 6-month, 1-arm, Open-label Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)
Primary Outcome Measures:
- Tolerability based on adverse events within 6 months after switch from MMF to an optimized enteric-coated mycophenolate sodium regimen.
Secondary Outcome Measures:
- Safety based on renal function within 6 months after medication switch.
- Pharmacokinetics of enteric-coated mycophenolate sodium in combination with tacrolimus in a subpopulation at baseline, week 2, month 3
- Influence of enteric-coated mycophenolate sodium on the activity of an enzyme at baseline, week 2, month 3
- Incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.
- Graft survival and patient survival 6 months post medication switch.
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||February 2005 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
- Recipients of first or secondary cadaveric heart-beating, living unrelated or living related kidney transplant.
- Currently receiving 1, 1.5, or 2 g MMF/day, tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months.
- In a stable condition in terms of graft function.
- Patients who had taken an investigational drug within four weeks prior to study entry
- History of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.
- Thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<2,500/mm3), and/or hemoglobin <6.0 g/dL prior to enrollment
- Clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, evidence of severe liver disease, HIV or Hepatitis B surface antigen positive.
Other protocol-defined inclusion/exclusion criteria may apply.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00238979
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 12, 2005
||November 1, 2011
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Novartis:
Renal transplantation, Enteric-coated mycophenolate sodium
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs