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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171496

Enrollment

693

Registered

2005-09-15

Start date

2003-10-31

Completion date

2006-03-31

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant

Keywords

Kidney transplant, adults, NODM, immunosuppressants

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

Interventions

DRUGCyclosporine microemulsion

DRUGTacrolimus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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.	—
Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation.	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026