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

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ClinicalTrials.gov Identifier: NCT00171743
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 7, 2017
Sponsor:
Information provided by:
Novartis

Brief Summary:
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 or disease Intervention/treatment Phase
Liver Transplant Drug: Cyclosporine microemulsion Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (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)
Study Start Date : April 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171743


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis

Additional Information:
Publications of Results:
Responsible Party: External Affairs, Novartis Pharmaceticals
ClinicalTrials.gov Identifier: NCT00171743     History of Changes
Other Study ID Numbers: COLO400AIT03
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017

Keywords provided by Novartis:
Adults
Post transplant diabetes

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