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OpenTrials
Completed

NCT Number: NCT00149929

Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301

Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from 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

Healthy volunteers accepted: No

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

Inclusion criteria

-First cadaveric, living unrelated or human antigen mismatched living related donor kidney transplant recipients who completed study CERL080A301

Exclusion criteria

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

Treatment and study plan

Mycophenolate sodium (enteric coated)

Drug

Primary outcomes

  1. Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment.

Secondary outcomes

  1. Incidence of biopsy proven acute rejection in the first six months of treatment in de novo renal transplant recipients.

  2. Efficacy of enteric-coated mycophenolate sodium

  3. Safety of enteric-coated mycophenolate sodium based on AE reporting.

  4. Pharmacokinetics (PK) of enteric-coated mycophenolate sodium (selected centers only).

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 de Novo Renal Transplant Patients

Important dates

Study start
1999
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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