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

Kidney Transplant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171496
• Other study ID #: COLO400A2419
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: November 16, 2016
• Start date: October 2003
• Est. completion date: March 2006

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 693
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Kidney Transplant

Intervention

Drug:
• Cyclosporine microemulsion

• Tacrolimus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

References & Publications (1)

Ekmekçioglu O, Turkan S, Yildiz S, Günes ZE. Comparison of tacrolimus with a cyclosporine microemulsion for immunosuppressive therapy in kidney transplantation. Turk J Urol. 2013 Mar;39(1):16-21. doi: 10.5152/tud.2013.004. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation.
Secondary	incidence of NODM or IFG within the first 3 mths post-transplantation in pts treated with cyclosporine microemulsion or tacrolimus
Secondary	percentage of pts with preexisting diabetes at transplantation who have a glycosylated hemoglobin level >7% at Mths 3 &6 post-transplantation
Secondary	Change over time of mean HbA1c at mths 3 &6 post-transplantation in pts w/ preexisting diabetes at transplantation
Secondary	percentage of pts who switched from oral hypoglycemic agents to insulin within 3 &6 mths post-transplantation
Secondary	incidence of impaired glucose tolerance (IGT) as assessed by an oral glucose tolerance test (OGTT)		6 months
Secondary	Blood pressure at Months 3& 6 post-transplantation
Secondary	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.

External Links

•   Results for COLO400A2419 from the Novartis Clinical Trials website