Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107

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. Identifier: NCT00149916
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 2, 2011
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
Aim of study is to provide safety and tolerability data on enteric-coated mycophenolate sodium in regard to adverse events, serious adverse events and patient and graft survival. After successful completion of the study CERL080A0107 study, patients could continue to receive enteric-coated mycophenolate sodium.

Condition or disease Intervention/treatment Phase
Renal Transplant Drug: Mycophenolate sodium (enteric coated) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Patients.
Study Start Date : April 2000
Actual Primary Completion Date : April 2004

Arm Intervention/treatment
Experimental: Mycophenolate sodium (enteric coated) Drug: Mycophenolate sodium (enteric coated)

Primary Outcome Measures :
  1. To assess gastro-intestinal tolerability

Secondary Outcome Measures :
  1. Efficacy/safety of enteric-coated mycophenolate sodium based on AE reporting.

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

Inclusion Criteria:

  • Cadaveric or living donor kidney transplant recipients who completed the study CERL080A0107

Exclusion Criteria:

  • Other protocol-defined inclusion/exclusion criteria may apply.

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 identifier (NCT number): NCT00149916

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Novartis

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00149916     History of Changes
Other Study ID Numbers: CERL080A107E
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Renal Transplant, adults, immunosuppressants

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