Status:
COMPLETED
Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients
Lead Sponsor:
Novartis
Conditions:
Kidney Transplantation
Eligibility:
All Genders
6+ years
Phase:
PHASE4
Brief Summary
The aim of MYFORMS is to assess efficacy and safety on clinical outcomes of EC-MPS in combination with Cyclosporine microemulsion (CsA-ME) in kidney transplant recipients.
Eligibility Criteria
Inclusion
- De Novo-Inclusion criteria
- Males and females aged 6 years or over.
- Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-Me, with or without corticosteroids, as primary immunosuppression.
- Maintenance-Inclusion criteria
- Males and females aged 6 years or over.
- Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant.
- Patients currently receiving CsA-ME with or without Mycophenolate mofetil (MMF) or azathioprine, with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months prior to Screening.
- Patients in a stable condition in terms of graft function (serum creatinine not above 2.3 mg/dL (=204 µmol/L) at screening and at baseline, or not increased by more than 20% at baseline compared to values obtained at screening), no change of immune suppressive regimen due to graft malfunction, and any known clinically significant physical and/or laboratory changes for at least 2 months prior to enrollment.
- De Novo and Maintenance-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.
- Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00239083
Start Date
January 1 2005
End Date
August 1 2006
Last Update
February 23 2017
Active Locations (1)
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1
Novartis
Basel, Switzerland