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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150085

Enrollment

Registered

2005-09-08

Start date

2004-02-29

Completion date

2005-10-31

Last updated

2011-02-18

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

Conditions

Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients

Keywords

diabetes, glucose, tacrolimus, cyclosporine micro-emulsion, liver, kidney, renal

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.

Interventions

DRUGcyclosporine micro-emulsion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Outcome results

None listed

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