Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy - Full Text View

Sponsored by:	University of Oslo School of Pharmacy
Information provided by:	University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:	NCT00264368

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 IV

MedlinePlus related topics: Cytomegalovirus Infections Kidney Failure

Drug Information available for: Ganciclovir Ganciclovir sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

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

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

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

Keywords provided by University of Oslo School of Pharmacy:

Renal replacement therapy
CMV disease

Study placed in the following topic categories:

Renal Insufficiency
Ganciclovir
Cytomegalovirus
Herpesviridae Infections
Virus Diseases
Urologic Diseases
Shock
Multiple Organ Failure

Cytomegalovirus Infections
DNA Virus Infections
Kidney Failure, Acute
Kidney Diseases
Renal Insufficiency, Acute
Cytomegalic inclusion disease
Kidney Failure

Additional relevant MeSH terms:

Anti-Infective Agents
Pathologic Processes
Therapeutic Uses

Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009