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Completed

NCT Number: NCT00238966

Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

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Key information

Conditions

Renal Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

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

Inclusion/ Exclusion criteria

  • Only patients who were participating in study CERL080A2405-DE02 and have completed the first 6 months of the core study can be included in this additional extension study.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Drug

Primary outcomes

  1. Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.

Secondary outcomes

  1. Safety based on renal function within 6 months after medication switch.

  2. Pharmacokinetics (PK) in a randomized subpopulation.

  3. Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.

  4. Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch.

  5. Graft survival and patient survival 6 months post medication switch.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A One Arm, Open-label Study to Investigate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Recipients Who Received Mycophenolate Mofetil (MMF)

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Oct 14, 2005
Registry last updated
Jan 31, 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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