Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients

De Novo Kidney Transplantation Clinical Trial

Official title:

A Prospective, Open-label, Multicenter, Follow-up Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239018
• Other study ID #: CERL080A2405FR01E1
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2005
• Last updated: January 28, 2011
• Start date: April 2003
• Est. completion date: July 2005

Study information

• Verified date: January 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• 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 CERL080A2405FR01) to continue on the same treatment and to assess the long-term safety of EC-MPS

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion / Exclusion Criteria

• All patients who completed study CERL080A2405-FR01 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

• De Novo Kidney 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	To assess glomerular filtration rate at month 3 post transplantation
Secondary	Renal function of patients requiring post transplantation dialysis, experiencing slow graft function (defined as S. Creat level>264 µmol/l at D5) or with immediate graft function.
Secondary	Incidence of patients requiring post transplantation dialysis, experience slow graft function (defined as S. Creat level>264 µmol/l at D5 or with immediate graft function.
Secondary	Incidence of biopsy proven acute rejection, any treated acute rejection, and any treated acute rejection requiring antibody therapy, recurrent acute rejection and the severity of acute rejection episodes within 6 and 12 months
Secondary	Incidence of graft and patient survival within 6 and 12 months
Secondary	Safety and tolerability based on adverse event (AE) reporting.