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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00171509
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 1, 2011
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Liver Transplant Drug: Cyclosporine microemulsion Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : May 2004
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. assess the safety of a once a day administration of cyclosporine microemulsion.
  2. compare for each patient the C2 levels pre- and post-conversion.
  3. characterize the steady state pharmacokinetics of cyclosporine after conversion to once a day administration.
  4. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 1, 2011
Last Verified: January 2011

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