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

NCT00150085 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-02-18

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

cyclosporine micro-emulsion

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2005-10-31
Completion
2005-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00150085 on ClinicalTrials.gov