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

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.

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Key information

Conditions

Renal Transplant

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Mycophenolate sodium (enteric coated)

Drug

Primary outcomes

To assess gastro-intestinal tolerability

Secondary outcomes

Efficacy/safety of enteric-coated mycophenolate sodium based on AE reporting.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Patients.

Important dates

Study start: 2000
Primary completion: 2004
First posted: Sep 8, 2005
Registry last updated: Nov 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed