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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00171509
Other study ID # COLO400A2421
Secondary ID
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
Accepts healthy volunteers
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


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
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