Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00238940
First received: October 12, 2005
Last updated: January 28, 2011
Last verified: January 2011

October 12, 2005
January 28, 2011
February 2003
September 2005   (final data collection date for primary outcome measure)
Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.
Not Provided
Complete list of historical versions of study NCT00238940 on ClinicalTrials.gov Archive Site
  • Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation.
  • Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation
  • Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup
  • Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation.
  • Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation.
Not Provided
Not Provided
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Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants
A One-year, Randomized, Open Label, Parallel Group Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Either Full Dose or Reduced Dose Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Renal Transplantation
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
September 2005
September 2005   (final data collection date for primary outcome measure)

Inclusion/ Exclusion criteria

- All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS.

Other protocol-defined inclusion/exclusion criteria may apply.

Both
18 Years to 75 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
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NCT00238940
CERL080A2405DE01E1
Not Provided
Novartis, Novartis Pharmaceuticals
Novartis
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