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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00238940
First received: October 12, 2005
Last updated: January 28, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Renal Transplantation
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.

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

Enrollment: 55
Study Start Date: February 2003
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238940

Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00238940     History of Changes
Other Study ID Numbers: CERL080A2405DE01E1
Study First Received: October 12, 2005
Last Updated: January 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Renal transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS)

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014