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Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion

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. Identifier: NCT00150085
Recruitment Status : Terminated
First Posted : September 8, 2005
Last Update Posted : February 18, 2011
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Brief Summary:
New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.

Condition or disease Intervention/treatment Phase
Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients Drug: cyclosporine micro-emulsion Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open-label, Twenty-six Week Study of the Efficacy and Safety of Converting Kidney and Liver Transplant Recipients With Tacrolimus-associated Abnormal Glucose Metabolism to Cyclosporine Micro-emulsion With C2 Monitoring
Study Start Date : February 2004
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Proportion of patients who no longer require a hypoglycemic agent, or who move from insulin to an oral agent, or who no longer meet the American Diabetes Association criteria, or a relative improvement in mean glycosylated hemoglobin at 12 and 26 weeks

Secondary Outcome Measures :
  1. Safety assessed by death, graft loss, biopsy supported clinically manifested acute rejection, change in kidney function, change in liver function, serious adverse events and adverse events at 12 and 26 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Recipients of first or second cadaveric or living donor kidney transplantation or first cadaveric or living donor liver transplantation
  • Receiving tacrolimus as a primary immunosuppressant
  • Currently on any diabetic agent or meets the American Diabetes Association definition of diabetes mellitus

Exclusion Criteria:

  • History of treated diabetes mellitus prior to transplantation
  • Less than 2 weeks post-transplantation for kidney and less than 8 weeks for liver
  • Greater than 36 months post-transplantation
  • Onset of diabetes is greater than 12 months prior to time of study entry
  • Has unacceptable or unstable graft function

Other protocol-defined inclusion/exclusion criteria may apply.

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 identifier (NCT number): NCT00150085

Sponsors and Collaborators
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Study Director: Novartis Novartis

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Responsible Party: Novartis Identifier: NCT00150085     History of Changes
Other Study ID Numbers: COLO400AUS06
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: February 2011

Keywords provided by Novartis:
diabetes, glucose, tacrolimus, cyclosporine micro-emulsion, liver, kidney, renal

Additional relevant MeSH terms:
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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