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

Liver Transplantation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343226
• Other study ID #: CCHI621ABE02
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2006
• Last updated: August 24, 2010
• Start date: May 2002

Study information

• Verified date: August 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: April 2005
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Basiliximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation
Secondary	Frequency and severity of rejection episodes before 6 and 12 months post-transplantation
Secondary	Frequency of death, graft loss or retransplantation before 6 and 12 months post-transplantation
Secondary	Adverse events
Secondary	Duration of initial hospitalization and number or hospital re-admissions.