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Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00149929
First received: September 6, 2005
Last updated: February 1, 2011
Last verified: February 2011

September 6, 2005
February 1, 2011
December 1999
April 2003   (final data collection date for primary outcome measure)
Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment.
Not Provided
Complete list of historical versions of study NCT00149929 on ClinicalTrials.gov Archive Site
  • Incidence of biopsy proven acute rejection in the first six months of treatment in de novo renal transplant recipients.
  • Efficacy of enteric-coated mycophenolate sodium
  • Safety of enteric-coated mycophenolate sodium based on AE reporting.
  • Pharmacokinetics (PK) of enteric-coated mycophenolate sodium (selected centers only).
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Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301
Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in de Novo Renal Transplant Patients

Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated mycophenolate sodium.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Transplant
Drug: Mycophenolate sodium (enteric coated)
Not Provided
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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
246
April 2003
April 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

-First cadaveric, living unrelated or human antigen mismatched living related donor kidney transplant recipients who completed study CERL080A301

Exclusion Criteria:

  • Other protocol-defined inclusion/exclusion criteria may apply.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00149929
CERL080A301E
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Novartis
Novartis
Not Provided
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