Status:
COMPLETED
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
Lead Sponsor:
Novartis
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male and females aged 18 to 75
- Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression
- Exclusion criteria:
- Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
- Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).
- Patients with thrombocytopenia (\< 75,000/mm3), with an absolute neutrophil count of \< 1,500/mm3, and/or leukocytopenia (\< 2,500/mm3), and/or hemoglobin \< 6 g/dL at Screening or Baseline.
- Other inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00238953
Start Date
February 1 2005
End Date
June 1 2006
Last Update
February 23 2017
Active Locations (1)
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1
Novartis
Basel, Switzerland