Extension Study of 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: NCT00241059
• Other study ID #: CERL080A2405LA01E1
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2005
• Last updated: January 28, 2011
• Start date: August 2002
• Est. completion date: January 2005

Study information

• Verified date: January 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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 parameters and graft function in maintenance renal transplant recipients.
Secondary	Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.