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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171509

Purpose

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.

Condition	Intervention	Phase
Liver Transplant	Drug: Cyclosporine microemulsion	Phase IV

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Cyclosporin Cyclosporine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

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:

assess the safety of a once a day administration of Neoral.
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.
explore whether 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)
observed four months after conversion to Neoral OAD,
is higher than in those patients maintained on Neoral BID
over the same period of time.

Estimated Enrollment:	60
Study Start Date:	May 2004

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171509

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Study ID Numbers:	COLO400A2421
Study First Received:	September 12, 2005
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00171509
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Novartis:

Liver transplant, adults, once a day administration, Immunosuppressants

Study placed in the following topic categories:

Cyclosporine
Clotrimazole
Miconazole
Tioconazole
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antifungal Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009