Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants

Phase 3

Completed

• Conditions: Renal Transplantation

• Registration Number: NCT00238940
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2005-09
• Study Completion: 2005-09
• 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: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.

Secondary Outcome Measures

Name	Time	Method
Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation.
Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation.
Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation
Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup
Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation.