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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00229138
First received: September 27, 2005
Last updated: January 28, 2011
Last verified: January 2011
History of Changes

September 27, 2005
January 28, 2011
September 2005
March 2007   (final data collection date for primary outcome measure)
renal function at 6 months posttransplant as measured by glomerular filtration rate [ Time Frame: 6 months ]
Not Provided
Complete list of historical versions of study NCT00229138 on ClinicalTrials.gov Archive Site
  • Efficacy as measured by combined incidence of biopsyproven acute rejection episodes, graft loss, and death at 6 months
  • Renal function as measured by calculated creatinine clearance
  • Cockcroft-Gaultand serum creatinine at 6 months
  • Gastrointestinal tolerability as measured by gastrointestinal
  • symptom rating scale (GSRS) at various time points
  • Safety as measured by incidence of adverse events
  • Effects on glucose metabolism at months 3 and 6 after transplantation.
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients
A Six-month, Prospective, Multicenter, Open Label, Parallel, Randomized Study of the Safety, Tolerability and Efficacy of EC-MPS With Basiliximab, Corticosteroids and Two Different Levels of Tacrolimus in de Novo Renal Transplant Recipients

This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
Drug: EC-MPS, Tacrolimus
  • Experimental: reduced Tacrolimus
    Intervention: Drug: EC-MPS, Tacrolimus
  • Active Comparator: Reference Tacrolimus
    Intervention: Drug: EC-MPS, Tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
291
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney.
  • The renal cold ischemic time (CIT) must be <30 hours
  • The age of the donor must be between 10 and 65 years

Exclusion Criteria

  • Patients who have previously received an organ transplant
  • Patients who are recipients of a multiple organ transplants
  • Recipients of non heart-beating donor organs
  • ABO incompatibility against the donor

Other protocol-defined exclusion criteria may apply.
Both
18 Years to 70 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00229138
CERL080A2409
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
January 2011

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