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Safety and Efficacy of Conver...

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

Last Updated: 2011-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cyclosporine micro-emulsion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers