Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

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: NCT00238953
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : February 23, 2017
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Brief Summary:
Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Open Label Protocol to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
Study Start Date : February 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

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

Primary Outcome Measures :
  1. 6 Month evaluation
  2. patient and graft survival
  3. acute rejection (suspected or biopsy confirmed)
  4. graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate),
  5. infections, adverse events, serious adverse events.

Secondary Outcome Measures :
  1. Influence of parameters: demography, medical conditions, complications post transplantation on main clinical outcomes. 6 month evaluation

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion criteria:

  • Male and females aged 18 to 75
  • Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression

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.

Other 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 identifier (NCT number): NCT00238953

Basel, Switzerland
Sponsors and Collaborators
Study Director: Novartis Novartis

Additional Information:
Publications of Results:
Responsible Party: Novartis Identifier: NCT00238953     History of Changes
Other Study ID Numbers: CERL080APL01
First Posted: October 14, 2005    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Kidney transplantation
enteric-coated mycophenolate sodium

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action