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

Renal Transplantation Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238966
• Other study ID #: CERL080A2405DE02E1
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2005
• Last updated: January 28, 2011
• Start date: November 2002
• Est. completion date: April 2005

Study information

• Verified date: January 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• Enteric-Coated Mycophenolate Sodium (EC-MPS)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.
Secondary	Safety based on renal function within 6 months after medication switch.
Secondary	Pharmacokinetics (PK) in a randomized subpopulation.
Secondary	Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.
Secondary	Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch.
Secondary	Graft survival and patient survival 6 months post medication switch.