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

Liver Transplant Clinical Trial

Official title:

A Multicenter, Randomized Open-label Pilot Study to Explore the Benefit of a Conversion From a Twice a Day Administration of Cyclosporine Microemulsion to a Once a Day Administration and to Identify the C2 Ranges to Target After Conversion in Stable Liver Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171509
• Other study ID #: COLO400A2421
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: January 31, 2011
• Start date: May 2004
• Est. completion date: October 2005

Study information

• Verified date: January 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Drug:
• Cyclosporine microemulsion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	assess the safety of a once a day administration of cyclosporine microemulsion.
Secondary	compare for each patient the C2 levels pre- and post-conversion.
Secondary	characterize the steady state pharmacokinetics of cyclosporine after conversion to once a day administration.
Secondary	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