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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 September 01, 2015
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs