Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients

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: NCT00171496
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 18, 2016
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Brief Summary:
The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection

Condition or disease Intervention/treatment Phase
Kidney Transplant Drug: Cyclosporine microemulsion Drug: Tacrolimus Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 693 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Six-month Open Label, Multicenter, Randomized Study to Evaluate the Incidence of New Onset Diabetes Mellitus and Glucose Metabolism in Patients Receiving Cyclosporine Microemulsion With C-2 Monitoring Versus Tacrolimus After de Novo Kidney Transplantation
Study Start Date : October 2003
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cyclosporine microemulsion Drug: Cyclosporine microemulsion
Active Comparator: Tacrolimus Drug: Tacrolimus

Primary Outcome Measures :
  1. Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving cyclosporine microemulsion versus in patients receiving tacrolimus within the first 6 months post-transplantation.
  2. Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation.

Secondary Outcome Measures :
  1. incidence of NODM or IFG within the first 3 mths post-transplantation in pts treated with cyclosporine microemulsion or tacrolimus
  2. percentage of pts with preexisting diabetes at transplantation who have a glycosylated hemoglobin level >7% at Mths 3 &6 post-transplantation
  3. Change over time of mean HbA1c at mths 3 &6 post-transplantation in pts w/ preexisting diabetes at transplantation
  4. percentage of pts who switched from oral hypoglycemic agents to insulin within 3 &6 mths post-transplantation
  5. incidence of impaired glucose tolerance (IGT) as assessed by an oral glucose tolerance test (OGTT) [ Time Frame: 6 months ]
  6. Blood pressure at Months 3& 6 post-transplantation
  7. incidence of BPAR or graft loss or death within the first 3 months post-transplantation, as well as the incidence of each individual event within 3 and 6 months post-transplantation.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- First or second transplant, cadaveric or living donor

Exclusion Criteria:

  • Multi-organ or dual kidney transplants
  • Panel reactive antibodies >50%

Other protocol-defined inclusion/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 identifier (NCT number): NCT00171496

Sponsors and Collaborators
Study Director: Novartis Novartis

Additional Information:
Publications of Results:
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00171496     History of Changes
Other Study ID Numbers: COLO400A2419
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis:
Kidney transplant, adults, NODM, immunosuppressants

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
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