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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00238953
First received: October 12, 2005
Last updated: October 30, 2009
Last verified: October 2009
History of Changes
  Purpose

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 Intervention Phase
Renal Transplantation
 Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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

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

Enrollment: 30
Study Start Date: February 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EC MPS Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238953

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00238953     History of Changes
Other Study ID Numbers: CERL080APL01
Study First Received: October 12, 2005
Last Updated: October 30, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: National Health Service

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

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013