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OpenTrials
Completed

NCT Number: NCT00171496

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

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

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Key information

Conditions

Kidney Transplant

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclosporine microemulsion

Drug

Tacrolimus

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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