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 has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00343226
First received: May 30, 2006
Last updated: August 24, 2010
Last verified: August 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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.

Enrollment: 48
Study Start Date: May 2002
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  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 Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00343226     History of Changes
Other Study ID Numbers: CCHI621ABE02
Study First Received: May 30, 2006
Last Updated: August 24, 2010
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Novartis:
Basiliximab, transplantation, liver, renal function

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Basiliximab
Antibodies, Monoclonal
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014