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

• ClinicalTrials.gov Identifier: NCT00241059
• Recruitment Status: Completed
• First Posted: October 18, 2005
• Last Update Posted: January 31, 2011
• Sponsor: Novartis
• Information provided by: Novartis

Tracking Information

• First Submitted Date: October 14, 2005
• First Posted Date: October 18, 2005
• Last Update Posted Date: January 31, 2011
• Study Start Date: August 2002
• Actual Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 16, 2006): Safety parameters and graft function in maintenance renal transplant recipients.
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: August 16, 2006): Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
• 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Renal Transplantation
• Intervention: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

Study Arms

Experimental: EC-MPS arm

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 28, 2011): 183
• Original Enrollment: Not Provided
• Actual Study Completion Date: January 2005
• Actual Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00241059
• Other Study ID Numbers: CERL080A2405LA01E1
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: External Affairs, Novartis Pharmaceticals
• Study Sponsor: Novartis
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis

• PRS Account: Novartis
• Verification Date: January 2011