An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in de Novo Liver Transplantation.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00343226

Enrollment

Registered

2006-06-22

Start date

2002-05-31

Completion date

Unknown

Last updated

2010-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

Keywords

Basiliximab, transplantation, liver, renal function

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)

Interventions

DRUGBasiliximab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Inclusion criteria

* First cadaveric liver transplant * ABO identical or compatible graft

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation	—

Secondary

Measure	Time frame
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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026