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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
History of Changes
  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:

U.S. FDA Resources

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
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 May 21, 2013