Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration

Acute Renal Failure Clinical Trial

Official title:

Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866397
• Other study ID #: CIDOFOVIR_CVVH
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2013
• Last updated: June 4, 2013
• Start date: March 2002
• Est. completion date: March 2002

Study information

• Verified date: June 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

Cidofovir is an acyclic nucleotide analog with broad-spectrum antiviral activity against herpesviruses. Its potency in inhibiting HCMV has been shown in conventional in vitro studies. It is approved for the systemic treatment of human cytomegalovirus (HCMV) retinitis in patients with AIDS and as a second line therapy for HCMV infections not responding to ganciclovir or foscarnet.

In intensive care patients continuous venovenous haemofiltration (CVVH) is a well-established extracorporal renal replacement therapy with a high clearance rate.

Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVH are rare. Elimination of any given drug by renal replacement therapy is determined by several major factors which are membrane specific, due to physico-chemical properties of the drug and characteristics of the renal replacement technique used.

Study objective The trial is conducted to investigate the pharmacokinetics of cidofovir during CVVH in critically ill patients. It is suspected that Hemofiltration will influence cidofovir plasma levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 2002
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18 to 75 years

• Suspected of proven HCMV infection

• Suspected or proven resistancy of HCMV to the first line therapy (ganciclovir / foscarnet).

• Continuous venovenous hemodiafiltration (CVVHDF) due to acute or chronic renal failure.

Exclusion Criteria:

• Known history of hypersensitivity to cidofovir or probenecid.

• An expected survival of less than three days.

• Known alcohol dependency, epilepsy, pregnancy or liver failure.

• Infection with a ganciclovir or foscarnet susceptible HCMV strain

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Cytomegalovirus Retinitis

Intervention

Other:
• Cidofovir pharmacokinetics
Blood samples were drawn before and 15, 30, 60, 120, 240, 360, 720 and 1440 minutes after the start of the cidofovir infusion. Plasma and ultrafiltration samples were collected from the outlet of the ultrafiltrate compartment of the hemofilter.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AreaUnderCurve (AUC)	AUC (plasma concentration) of cidofovir during 24 hours of hemofiltration	24 hours	No
Secondary	half-life (t1/2) of cidofovir during hemofiltration		24 hours	No
Secondary	maximum and minimum plasma concentration (Cmax, Cmin) of cidofovir during hemofiltration		24 hours	No
Secondary	total body clearance (Cltot) of cidofovir during hemofiltration		24 hours	No
Secondary	hemofiltration clearance (ClHF) of cidofovir during hemofiltration		24 hours	No
Secondary	sieving coefficient of cidofovir during hemofiltration		24 hours	No
Secondary	elimination fraction of cidofovir during hemofiltration		24 hours	No