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OpenTrials
Completed

NCT Number: NCT00343226

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 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)

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Key information

Conditions

Liver Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Basiliximab

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2002
Primary completion
2005
First posted
Jun 22, 2006
Registry last updated
Aug 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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