NCT00343226

Brief Summary

The objectives of the study are:To compare the renal function of a quadruple immunosuppressive regimen (including basiliximab in combination with an optimized cyclosporine dose during the first weeks post-transplantation, mycophenolate mofetil and corticosteroids) versus a standard triple therapy regimen (including cyclosporine standard dose, mycophenolate mofetil and corticosteroids)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 22, 2006

Completed
Last Updated

August 25, 2010

Status Verified

August 1, 2010

Enrollment Period

2.9 years

First QC Date

May 30, 2006

Last Update Submit

August 24, 2010

Conditions

Liver Transplantation

Keywords

Basiliximab, transplantation, liver, renal function

Outcome Measures

Primary Outcomes (1)

  • Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation

Secondary Outcomes (4)

  • Frequency and severity of rejection episodes before 6 and 12 months post-transplantation

  • Frequency of death, graft loss or retransplantation before 6 and 12 months post-transplantation

  • Adverse events

  • Duration of initial hospitalization and number or hospital re-admissions.

Interventions

BasiliximabDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First cadaveric liver transplant
  • ABO identical or compatible graft

You may not qualify if:

  • Multiple organ transplant
  • renal impairment defined as glomerular filtration rate (GFR) \< 30 ml/min
  • Fulminant liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Basiliximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2006

First Posted

June 22, 2006

Study Start

May 1, 2002

Primary Completion

April 1, 2005

Last Updated

August 25, 2010

Record last verified: 2010-08