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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: September 6, 2005
Last updated: November 1, 2011
Last verified: November 2011
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

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)

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both

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.

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Please refer to this study by its identifier: NCT00149903

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
Study Director: Novartis Novartis
  More Information

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT00149903     History of Changes
Other Study ID Numbers: CERL080A2305 
Study First Received: September 6, 2005
Last Updated: November 1, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 23, 2016