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

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ClinicalTrials.gov Identifier: NCT00149903
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Renal Transplant Drug: Mycophenolate sodium (enteric coated) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Study Start Date : January 2005
Primary Completion Date : June 2006


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Incidence of biopsy proven acute rejection within six months of treatment in de novo renal transplant recipients
  2. Other variables of efficacy: chronic rejection, graft loss, death.
  3. Safety of EC-MPS as measured by incidence of adverse events and serious adverse events.

Eligibility Criteria

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 Posted: September 8, 2005    Key Record Dates
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