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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014