Text Size

Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00149903
First received: September 6, 2005
Last updated: November 1, 2011
Last verified: November 2011
History of Changes

September 6, 2005
November 1, 2011
January 2005
June 2006   (final data collection date for primary outcome measure)
Efficacy of EC-MPS compared to MMF in Chinese patients as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant recipients.
Not Provided
Complete list of historical versions of study NCT00149903 on ClinicalTrials.gov Archive Site
  • Incidence of biopsy proven acute rejection within six months of treatment in de novo renal transplant recipients
  • Other variables of efficacy: chronic rejection, graft loss, death.
  • Safety of EC-MPS as measured by incidence of adverse events and serious adverse events.
Not Provided
Not Provided
Not Provided
 
Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients
Multicenter, Double-blind, Randomized, Parallel Group Study on Efficacy and Safety of Enteric-coated Mycophenolate Sodium vs. Mycophenolate Mofetil in de Novo Chinese Renal Transplant Recipients

Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Renal Transplant
Drug: Mycophenolate sodium (enteric coated)
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
300
Not Provided
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Recipients of first, cadaveric (with donor written consent form) or living related non-HLA identical donor kidney transplant,
  • treated with cyclosporine and corticosteroids as primary immunosuppression.

Exclusion Criteria:

  • Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ
  • Patients who have received an investigational drug within four weeks prior to study entry

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
China
 
NCT00149903
CERL080A2305
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
November 2011

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