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

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 4


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

Resource links provided by NLM:

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Cyclosporine

U.S. FDA Resources

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 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) [ Time Frame: 4 months ]


Enrollment:	61
Study Start Date:	May 2004
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: BID cyclosporine control group continuing with a BID administration of cyclosporine and C2 monitoring.	Drug: Cyclosporine microemulsion
Experimental: OAD cyclosporine conversion to OAD administration of cyclosporine with the same daily dose as received prior to conversion	Drug: Cyclosporine microemulsion
Experimental: OAD cyclosporine reduced OAD administration of cyclosporine with a daily dose adjusted to a reduced C2	Drug: Cyclosporine microemulsion

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis	Novartis

More Information


Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00171509 History of Changes
Other Study ID Numbers:	COLO400A2421
Study First Received:	September 12, 2005
Last Updated:	January 31, 2011
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Novartis:


Liver transplant, adults, once a day administration, Immunosuppressants

Additional relevant MeSH terms:


Cyclosporins Cyclosporine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors	Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Calcineurin Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016