Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients

Phase 4

Completed

• Conditions: Liver Transplant
• Interventions: Drug: Cyclosporine microemulsion

• Registration Number: NCT00171509
• Lead Sponsor: Novartis

Brief Summary

The purpose of this study is to determine whether cyclosporine microemulsion given once a day instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose control in stable liver transplant recipients. The study also aims to identify the target ranges of levels of cyclosporine microemulsion in the blood.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-31
• Last Update Posted: 2011-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• At least 6 months post-transplant
• At least one of the following: stable or deteriorating kidney function, high blood pressure, high lipids, high glucose
• Receiving stable doses of cyclosporine microemulsion for the past 3 months

Exclusion Criteria

• • Severe rejection within the past 3 months
• Severe kidney dysfunction
• Transplanted for hepatitis C or autoimmune hepatitis

Other protocol-defined exclusion criteria applied

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
BID cyclosporine	Cyclosporine microemulsion	control group continuing with a BID administration of cyclosporine and C2 monitoring.
OAD cyclosporine	Cyclosporine microemulsion	conversion to OAD administration of cyclosporine with the same daily dose as received prior to conversion
OAD cyclosporine reduced	Cyclosporine microemulsion	OAD administration of cyclosporine with a daily dose adjusted to a reduced C2

Primary Outcome Measures

Name	Time	Method
Investigation of the proportion of patients with an improving GFR in the groups converted to OAD in comparison with the BID group 15 weeks after conversion.

Secondary Outcome Measures

Name	Time	Method
assess the safety of a once a day administration of cyclosporine microemulsion.
compare for each patient the C2 levels pre- and post-conversion.
characterize the steady state pharmacokinetics of cyclosporine after conversion to once a day administration.
the proportion of patients with improving renal function or blood pressure or lipid levels or glucose control (as a composite end point as well as each parameter assessed individually)	4 months