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

Novartis

Status and phase: Completed; Phase 4

Conditions: Liver Transplant

Treatments: Drug: Cyclosporine microemulsion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171509

COLO400A2421

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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61 participants in 3 patient groups

BID cyclosporine

Active Comparator group

Description:

control group continuing with a BID administration of cyclosporine and C2 monitoring.

Treatment:

Drug: Cyclosporine microemulsion

OAD cyclosporine

Experimental group

Description:

conversion to OAD administration of cyclosporine with the same daily dose as received prior to conversion

Treatment:

Drug: Cyclosporine microemulsion

OAD cyclosporine reduced

Experimental group

Description:

OAD administration of cyclosporine with a daily dose adjusted to a reduced C2

Treatment:

Drug: Cyclosporine microemulsion