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
  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
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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov 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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014