Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

This study has been terminated.
Sponsor:
Information provided by:
University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:
NCT00264368
First received: December 9, 2005
Last updated: June 27, 2007
Last verified: June 2007
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00264368     History of Changes
Other Study ID Numbers: GCV-PRISMA
Study First Received: December 9, 2005
Last Updated: June 27, 2007
Health Authority: Norway: Norwegian Medicines Agency

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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014