Status:
COMPLETED
Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients
Lead Sponsor:
Novartis
Conditions:
Kidney Diseases
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal fun...
Eligibility Criteria
Inclusion
- Primary or secondary kidney transplant
- Treatment with mycophenolic acid (MMF 1 g/d or EC-MPS 720 mg/d) and tacrolimus (trough concentration \[C0\] ≥ 5.5 ng/mL)
- Creatinine clearance ≥ 30 mL/min and \< 60 mL/min and stable renal function
Exclusion
- Multi-organ recipients or previous transplant with any other organ different from kidney
- Biopsy proven acute rejection or treated acute rejection within the last 3 months.
- Prescription of mycophenolate mofetil 1 g/d or mycophenolate sodium 720 mg/d due to adverse event occurrence when higher doses were administered
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00284934
Start Date
December 1 2005
End Date
June 1 2008
Last Update
May 2 2011
Active Locations (1)
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1
Novartis
Basel, Switzerland