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

NCT ID: NCT00343226

Last Updated: 2010-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Basiliximab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Other Identifiers

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CCHI621ABE02

Identifier Type: -

Identifier Source: org_study_id

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