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OpenTrials
Completed

NCT Number: NCT00171509

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

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.

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Key information

Conditions

Liver Transplant

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclosporine microemulsion

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Feb 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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