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

Phase 4

Completed

• Conditions: De Novo Kidney Transplantation

• Registration Number: NCT00239018
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-14
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-28
• Last Update Posted: 2011-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess glomerular filtration rate at month 3 post transplantation

Secondary Outcome Measures

Name	Time	Method
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.
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.
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
Incidence of graft and patient survival within 6 and 12 months
Safety and tolerability based on adverse event (AE) reporting.