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

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ClinicalTrials.gov Identifier: NCT00239083
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : February 23, 2017
Sponsor:
Information provided by:
Novartis

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : January 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006


Arm Intervention/treatment
Experimental: EC-MPS Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)



Primary Outcome Measures :
  1. patient and graft survival
  2. acute rejection incidence
  3. graft function
  4. safety

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239083


Locations
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis

Additional Information:
Publications of Results:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00239083     History of Changes
Other Study ID Numbers: CERL080ATR01
First Posted: October 14, 2005    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents