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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171509
First received: September 12, 2005
Last updated: January 31, 2011
Last verified: January 2011
  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:


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
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

No publications provided

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
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014