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

This study is ongoing, but not recruiting participants.

First Received: May 30, 2006 Last Updated: July 21, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00343226

Purpose

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)

Condition	Intervention	Phase
Liver Transplantation	Drug: Basiliximab	Phase IV

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Cyclosporine Cyclosporin Basiliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in "de Novo" Liver Transplantation.

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	48
Study Start Date:	May 2002

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

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 exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343226

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CCHI621ABE02
Study First Received:	May 30, 2006
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00343226 History of Changes
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Novartis:

Basiliximab, transplantation, liver, renal function

Study placed in the following topic categories:

Basiliximab
Cyclosporine
Immunologic Factors
Immunosuppressive Agents
Cyclosporins

Additional relevant MeSH terms:

Basiliximab
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Enzyme Inhibitors
Immunosuppressive Agents
Cyclosporins
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009