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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00343226
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : August 25, 2010
Sponsor:
Information provided by:

Study Description
Brief 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)

Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: Basiliximab Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : May 2002
Primary Completion Date : April 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation

Secondary Outcome Measures :
  1. Frequency and severity of rejection episodes before 6 and 12 months post-transplantation
  2. Frequency of death, graft loss or retransplantation before 6 and 12 months post-transplantation
  3. Adverse events
  4. Duration of initial hospitalization and number or hospital re-admissions.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343226


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00343226     History of Changes
Other Study ID Numbers: CCHI621ABE02
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: August 25, 2010
Last Verified: August 2010

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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors