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Follow-Up Study of Safety of Enteric-Coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107 - Article


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Nafcillin Sodium Injection

Nallpen; Unipen Injection



Clinical Trial: Follow-Up Study of Safety of Enteric-Coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107

This study is no longer recruiting patients.

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00149916

Purpose

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 Intervention Phase
Renal transplant
 Drug: Mycophenolate sodium (enteric coated)
Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title: Multicenter, Open-Label Follow-Up Study on the Safety of Enteric-Coated Mycophenolate Sodium in Renal Transplant Patients.

Further Study Details: 

Study start: March 2000

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Location Information

Study chairs or principal investigators

Novartis,  Study Director,  Novartis   

More Information

Study ID Numbers:  CERL080A107E
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00149916
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13

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November 18, 2008



Page Updated: June 1, 2005
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