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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239083
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : February 23, 2017
Information provided by:

October 12, 2005
October 14, 2005
February 23, 2017
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 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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Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Nart A, Sipahi S, Aykas A, Uslu A, Hoşcoşkun C, Toz H. Efficacy and safety of enteric-coated mycophenolate sodium in de novo and maintenance renal transplant patients. Transplant Proc. 2008 Jan-Feb;40(1):189-92. doi: 10.1016/j.transproceed.2007.11.066.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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

Sexes Eligible for Study: All
6 Years and older   (Child, Adult, Older Adult)
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Contact information is only displayed when the study is recruiting subjects
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Study Director: Novartis Novartis
February 2017

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