Status:
COMPLETED
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)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00238979
Start Date
January 1 2003
Last Update
November 2 2011
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