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NCT00239070 Clinical Trial

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

Renal Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00239070
Other study ID # CERL080A2405IN01E1
Secondary ID
Status Completed
Phase Phase 3
First received October 12, 2005
Last updated January 28, 2011
Start date April 2003
Est. completion date May 2006

Study information
Verified date January 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial Summary

This extension study is to assess the long-term safety of EC-MPS

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date May 2006
Est. primary completion date May 2006
Accepts healthy volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion / Exclusion Criteria - All patients who completed study CERL080A2405-IN01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

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

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 To assess patient and graft survival, acute rejection incidence, graft function and specific pertinent safety parameters in de novo renal transplant recipients.
Secondary To assess the respective influence of parameters (demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications) on clinical outcomes.
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