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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149903
First Posted: September 8, 2005
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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.

Condition Intervention Phase
Renal Transplant Drug: Mycophenolate sodium (enteric coated) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 300
Study Start Date: January 2005
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149903


Locations
China
General Hospital, Friendship Hospital, Beijing, No 1 Hospital Peking University, Beijing China; Shanghai No 1 Hospital, Shanghai China; Changzheng Hospital, Shanghai, China; Shanghai Ruij
Beijing, China
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00149903     History of Changes
Other Study ID Numbers: CERL080A2305
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: November 18, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action