NCT00171509

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

Enrollment Period

1.4 years

First QC Date

September 12, 2005

Last Update Submit

January 31, 2011

Conditions

Liver Transplant

Keywords

Liver transplant, adults, once a day administration, Immunosuppressants

Outcome Measures

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 (4)

  • 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)

    4 months

Study Arms (3)

BID cyclosporine

ACTIVE COMPARATOR

control group continuing with a BID administration of cyclosporine and C2 monitoring.

Drug: Cyclosporine microemulsion

OAD cyclosporine

EXPERIMENTAL

conversion to OAD administration of cyclosporine with the same daily dose as received prior to conversion

Drug: Cyclosporine microemulsion

OAD cyclosporine reduced

EXPERIMENTAL

OAD administration of cyclosporine with a daily dose adjusted to a reduced C2

Drug: Cyclosporine microemulsion

Interventions

Cyclosporine microemulsionDRUG
BID cyclosporineOAD cyclosporineOAD cyclosporine reduced

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Severe rejection within the past 3 months
  • Severe kidney dysfunction
  • Transplanted for hepatitis C or autoimmune hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

May 1, 2004

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

February 1, 2011

Record last verified: 2011-01