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Completed

NCT Number: NCT00239018

Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to assess the long-term safety of EC-MPS

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Key information

Conditions

De Novo Kidney 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

  • All patients who completed study CERL080A2405-FR01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Other protocol-defined inclusion / exclusion criteria may apply

Treatment and study plan

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Drug

Primary outcomes

  1. To assess glomerular filtration rate at month 3 post transplantation

Secondary outcomes

  1. Renal function of patients requiring post transplantation dialysis, experiencing slow graft function (defined as S. Creat level>264 μmol/l at D5) or with immediate graft function.

  2. Incidence of patients requiring post transplantation dialysis, experience slow graft function (defined as S. Creat level>264 μmol/l at D5 or with immediate graft function.

  3. Incidence of biopsy proven acute rejection, any treated acute rejection, and any treated acute rejection requiring antibody therapy, recurrent acute rejection and the severity of acute rejection episodes within 6 and 12 months

  4. Incidence of graft and patient survival within 6 and 12 months

  5. Safety and tolerability based on adverse event (AE) reporting.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Prospective, Open-label, Multicenter, Follow-up Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients

Important dates

Study start
2003
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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