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:
NCT00312143
First received: April 5, 2006
Last updated: February 1, 2011
Last verified: February 2011

April 5, 2006
February 1, 2011
February 2004
October 2005   (final data collection date for primary outcome measure)
  • patient and graft survival
  • acute rejection incidence
  • graft function at 6 months post transplant.
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Complete list of historical versions of study NCT00312143 on ClinicalTrials.gov Archive Site
influence of age, gender, and post-transplantation complications on the main clinical outcomes
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Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
A Prospective, Open Label, Multicenter Study to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

This trial is designed to assess the efficacy, tolerability, and safety of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in kidney transplant recipients.

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Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
De Novo Kidney Transplant Recipients
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
October 2005
October 2005   (final data collection date for primary outcome measure)

Inclusion criteria

  1. Males and females aged 18 to 75 years.
  2. Recipients of living related kidney transplant, treated with cyclosporine, with or without corticosteroids, as primary immunosuppression.
  3. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to or at screening. Effective contraception must be used during the trial, and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
  4. Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

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 other components of the formulation (e.g. lactose).
  3. Patients with low platelet count (< 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 who have received an investigational drug within four weeks prior to study entry.
  5. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
  6. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.

Additional protocol-defined inclusion/exclusion criteria may apply

Both
18 Years to 75 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00312143
CERL080AEG01
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Novartis
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Study Director: Novartis Novartis
Novartis
February 2011

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