Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00241059
First received: October 14, 2005
Last updated: January 28, 2011
Last verified: January 2011
  Purpose

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.


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 Prospective, Open-label, Multicenter, International Follow-up Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety parameters and graft function in maintenance renal transplant recipients.

Secondary Outcome Measures:
  • Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.

Enrollment: 183
Study Start Date: August 2002
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EC-MPS arm Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who completed study CERL080A2405-LA01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Exclusion Criteria:

  • 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: NCT00241059

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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceticals
ClinicalTrials.gov Identifier: NCT00241059     History of Changes
Other Study ID Numbers: CERL080A2405LA01E1
Study First Received: October 14, 2005
Last Updated: January 28, 2011
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Novartis:
Renal transplantation, maintenance patients, tolerability, 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 30, 2014