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OpenTrials
Completed

NCT Number: NCT00149864

Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302

Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720 mg bid in combination with cyclosporine with/without steroids in regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of the study CERL080A302, patients who previously were receiving enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert MMF to 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

-First cadaveric, living unrelated or living related donor kidney transplant recipients who completed study CERL080A302

Exclusion criteria

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

Treatment and study plan

Mycophenolate sodium (enteric coated)

Drug

Primary outcomes

  1. To assess the incidence and severity of GI adverse events (AEs) and neutropenia in the first 3 months of treatment in maintenance renal transplant patients.

Secondary outcomes

  1. Safety/efficacy based on adverse event (AE) reporting.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2003
Study completion
2003
First posted
Sep 8, 2005
Registry last updated
Feb 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.

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