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Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients
This study is currently recruiting participants.
Verified by Novartis, September 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00239083
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Phase IV

MedlinePlus related topics: Dietary Sodium Kidney Transplantation
Drug Information available for: Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Mycophenolate sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • patient and graft survival
  • acute rejection incidence
  • graft function
  • safety

Secondary Outcome Measures:
  • influence of demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications on the main clinical outcomes, according to the immunosuppressive regimen used.

Estimated Enrollment: 40
Study Start Date: January 2005
  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239083

Contacts
Contact: novartis 41613241111

Locations
Switzerland
Novartis Recruiting
Basel, Switzerland
Contact: novartis     41 61 324 1111        
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

Responsible Party: Novartis ( Novartis )
Study ID Numbers: CERL080ATR01
Study First Received: October 12, 2005
Last Updated: September 5, 2008
ClinicalTrials.gov Identifier: NCT00239083  
Health Authority: Turkey: Ministry of Health

Keywords provided by Novartis:
MYFORMS, Kidney Transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS), Cyclosporine microemulsion (CsA-ME)

Study placed in the following topic categories:
Cyclosporine
Mycophenolate mofetil
Cyclosporins

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009