Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants

Renal Transplantation Clinical Trial

Official title:

A One-year, Randomized, Open Label, Parallel Group Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Either Full Dose or Reduced Dose Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238940
• Other study ID #: CERL080A2405DE01E1
• Status: Completed
• Phase: Phase 3
• First received: October 12, 2005
• Last updated: January 28, 2011
• Start date: February 2003
• Est. completion date: September 2005

Study information

• Verified date: January 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion/ Exclusion criteria

• All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS.

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	Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.
Secondary	Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation.
Secondary	Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation
Secondary	Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup
Secondary	Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation.
Secondary	Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation.