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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00238966
First received: October 12, 2005
Last updated: January 28, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Renal Transplantation
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.

Secondary Outcome Measures:
  • Safety based on renal function within 6 months after medication switch.
  • Pharmacokinetics (PK) in a randomized subpopulation.
  • Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.
  • Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch.
  • Graft survival and patient survival 6 months post medication switch.

Enrollment: 187
Study Start Date: November 2002
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238966

Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00238966     History of Changes
Other Study ID Numbers: CERL080A2405DE02E1
Study First Received: October 12, 2005
Last Updated: January 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Renal transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS)

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014