Efficacy and Safety of Cyclosporine Microemulsion in Diabetic Adult Stable Liver Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171743
First received: September 13, 2005
Last updated: January 31, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to determine whether the switch from tacrolimus to cyclosporine microemulsion benefits post-transplant diabetes management (in terms of glycogenic control and insulin dosage) in stable liver transplant recipients.


Condition Intervention Phase
Liver Transplant
Drug: Cyclosporine microemulsion
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Switch From Tacrolimus to Cyclosporine Microemulsion: Immunosuppressive Agents and Diabetes Management in Liver Transplant Recipients in Maintenance (DIALIVER)

Resource links provided by NLM:


Further study details as provided by Novartis:

Enrollment: 47
Study Start Date: April 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • At least 4 months post-transplant
  • Patients in treatment with tacrolimus
  • Post-transplant diabetes treated with insulin for at least one month

Exclusion Criteria

  • Known hypersensitivity to cyclosporine microemulsion
  • Investigational drug within 60 days before baseline or during the study
  • Patients who cannot comply with the study requirements

Other protocol-defined exclusion criteria applied

  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: NCT00171743

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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceticals
ClinicalTrials.gov Identifier: NCT00171743     History of Changes
Other Study ID Numbers: COLO400AIT03
Study First Received: September 13, 2005
Last Updated: January 31, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Novartis:
Adults
Post transplant diabetes

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

ClinicalTrials.gov processed this record on August 28, 2014