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Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00264368
First Posted: December 12, 2005
Last Update Posted: June 28, 2007
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.
Information provided by:
University of Oslo School of Pharmacy
  Purpose

In order to optimize anti-cytomegalovirus (CMV) treatment with ganciclovir (GCV), in patients with multi organ failure treated with continuous renal replacement therapy (RRT), more information about ganciclovir pharmacokinetics in this setting is needed.

The primary objective is to describe the pharmacokinetics of ganciclovir in critically ill patients with acute renal failure treated with continuous renal replacement therapy, with a special emphasis on the extra-renal clearance and distribution volume.

Secondary objectives are to investigate if any co-factors, such as serum creatinine, weight, general hydration status, rest function of the native kidneys, etc. can help to describe the pharmacokinetics of GCV in these patients on continuous RRT as well as the relative influence of filtrations and dialysis on GCV elimination during different modalities of the treatment.


Condition Intervention Phase
Acute Renal Failure Cytomegalovirus Infections Multi Organ Failure Drug: intravenous (IV) ganciclovir Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

Resource links provided by NLM:


Further study details as provided by University of Oslo School of Pharmacy:

Primary Outcome Measures:
  • comparing the total clearance with the RRT derived clearance of GCV
  • comparing the volume of distribution with historic controls of non Intensive Care Unit (ICU) patients

Secondary Outcome Measures:
  • comparing GCV plasma concentration and population model derived estimates of these concentrations when including different relevant clinical co-factors such as: weight, S-creatinine, CL-creatinine, hydration, albumin, rest function of native kidneys etc.
  • determine RRT derived GCV clearance during the different filtration/dialysis settings of the RRT machine

Estimated Enrollment: 6
Study Start Date: December 2005
Study Completion Date: June 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in need of continuous RRT and GCV treatment
  • 18 years of age or older.

Exclusion Criteria:

  • Concomitant treatment with acyclovir or valacyclovir.
  • Patient does not give informed consent.
  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): NCT00264368


Locations
Norway
Rikshospitalet, Section of Nephrology
Oslo, Norway, 0027
Sponsors and Collaborators
University of Oslo School of Pharmacy
Investigators
Study Director: Anders Åsberg, Ph.D. University of Oslo School of Pharmacy
Principal Investigator: Anders Hartmann, MD, Ph.D. Rikshospitalet, Medical Department
Study Chair: Jan F Bugge, MD, Ph.D. Rikshospitalet, Department of Anaesthesiology
  More Information

ClinicalTrials.gov Identifier: NCT00264368     History of Changes
Other Study ID Numbers: GCV-PRISMA
First Submitted: December 9, 2005
First Posted: December 12, 2005
Last Update Posted: June 28, 2007
Last Verified: June 2007

Keywords provided by University of Oslo School of Pharmacy:
Renal replacement therapy
CMV disease

Additional relevant MeSH terms:
Renal Insufficiency
Cytomegalovirus Infections
Acute Kidney Injury
Multiple Organ Failure
Kidney Diseases
Urologic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Shock
Pathologic Processes
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action