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Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients With New Onset Diabetes After the 3rd Month Post-transplant

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171717
First Posted: September 15, 2005
Last Update Posted: February 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
The trial is conducted in patients who have received a liver transplant, were prescribed tacrolimus to prevent organ rejection and developed diabetes from 3 month post-transplantation onwards. The goal of the trial is to assess the percentage of patients in whom diabetes will resolve 6 month after conversion from tacrolimus to cyclosporine micro-emulsion as measured by a fasting blood glucose < 1,26 g/l without the need of hypoglycemic treatment.

Condition Intervention Phase
Maintenance Liver Transplant Patients With New Onset Diabetes Drug: Cyclosporine - cyclosporine microemulsion Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients Presenting With New Onset Diabetes After the 3rd Month Post-transplant.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • % of patients whose diabetes resolves 6 months after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).

Secondary Outcome Measures:
  • % of patients whose diabetes has resolved 1 year after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).
  • % of patients treated with insulin and oral ant diabetics and status of the drug doses 6 months and 1 year after the conversion.
  • % of patients with HbA1c ≤ 7% 6 months and 1 year after the conversion.
  • Blood pressure % of patients with a diastolic value ≥ 90 mmHg, mean systolic and diastolic values,
  • % of patients receiving antihypertensive treatment),
  • BMI, kidney function (creatinine and creatinine clearance), microalbuminuria, hyperlipidemia, adverse events, serious adverse events, dropouts, at 6 months and at 1 year.
  • Incidence of acute and chronic rejection treated at 6 months and at 1 year.

Enrollment: 39
Study Start Date: February 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • - Patients who have received a first liver transplantation and who are 18 to 70 year old
  • Patients who are treated with tacrolimus post-transplant for at least 3 months and for a maximum of 36 months
  • Patients without any known diabetes before transplantation and in whom diabetes mellitus was diagnosed for the first time at least 3 months post-transplantation

Exclusion Criteria

  • Re-transplantation or multi-organ transplantation,
  • Diabetes before the transplantation,
  • Type I diabetes mellitus.

Other protocol-defined inclusion / exclusion criteria may apply

  Contacts and Locations
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): NCT00171717


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00171717     History of Changes
Other Study ID Numbers: COLO400AFR04
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: February 1, 2011
Last Verified: January 2011

Keywords provided by Novartis:
Cyclosporine, liver transplantation, maintenance, diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Tacrolimus
Cyclosporins
Cyclosporine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents