Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00239083
First received: October 12, 2005
Last updated: October 30, 2009
Last verified: October 2009

October 12, 2005
October 30, 2009
January 2005
August 2006   (final data collection date for primary outcome measure)
  • patient and graft survival
  • acute rejection incidence
  • graft function
  • safety
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Complete list of historical versions of study NCT00239083 on ClinicalTrials.gov Archive Site
influence of demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications on the main clinical outcomes, according to the immunosuppressive regimen used.
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Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients
Phase IV Study of Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Kidney Transplant Patients

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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Kidney Transplantation
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Experimental: EC-MPS
Intervention: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2006
August 2006   (final data collection date for primary outcome measure)

De Novo-Inclusion criteria

  1. Males and females aged 6 years or over.
  2. Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-Me, with or without corticosteroids, as primary immunosuppression.

Maintenance-Inclusion criteria

  1. Males and females aged 6 years or over.
  2. Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant.
  3. 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.
  4. 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

  1. Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
  2. Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).
  3. 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.
  4. 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

Both
6 Years and older
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Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00239083
CERL080ATR01
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Novartis
Novartis
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Study Director: Novartis Novartis
Novartis
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP