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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00238940
• Collaborator: (none)
• Enrollment: 55
• Duration (Months): 31

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Transplantation	Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Study Start Date: Feb 1, 2003
• Actual Primary Completion Date: Sep 1, 2005
• Actual Study Completion Date: Sep 1, 2005

Outcome Measures

Primary Outcome Measures

1. Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation. []

Secondary Outcome Measures

1. Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation. []

2. Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation []

3. Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup []

4. Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation. []

5. Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00238940
• Other Study ID Numbers: CERL080A2405DE01E1
• First Posted: Oct 14, 2005
• Last Update Posted: Jan 31, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: Renal transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS)
• Additional relevant MeSH terms: Mycophenolic Acid

Study Results

No Results Posted as of Jan 31, 2011