Pharmacokinetic Assessment of Peramivir in Hospitalized Adults Undergoing Continuous Renal Replacement Therapy

Influenza Clinical Trial

Official title:

Pharmacokinetic Assessment of Peramivir in Hospitalized Adults Undergoing Continuous Renal Replacement Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01146353
• Other study ID #: STU00023343
• Status: Withdrawn
• First received: June 16, 2010
• Last updated: March 17, 2018
• Start date: February 2010
• Est. completion date: February 2011

Study information

• Verified date: March 2018
• Source: Midwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pharmacokinetics for peramivir have not been well characterized in patients undergoing continuous renal replacement therapy CRRT - either Continuous veno-venous hemofiltration (CVVH) +/- dialysis (CVVHD). CRRT is commonly utilized in the hospital setting for patients with acute kidney injury for metabolic correction, slow continuous fluid removal, and to maintain hemodynamic stability. CRRT commonly alters drug disposition and clearance, and dosing regimens often need alteration in patients receiving CRRT. Doses required to generate predictable serum concentrations can be calculated from known patient parameters such as replacement fluid and dialysate flow rate, sieving coefficients, and desired serum concentrations. However, pharmacokinetic studies must be performed in CRRT patients to generate drug removal constants or sieving coefficients. Of note, the clearance of drugs by conventional hemodialysis cannot be used to extrapolate clearances with CRRT secondary to differences in ultrafiltration rates and dialysis membranes. The investigators propose an open label study to obtain peramivir pharmacokinetics in patients undergoing CRRT.

Description:

This study has been closed. No patients were enrolled as the peramivir EUA was rescinded.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Patient is hospitalized and undergoing continuous renal replacement therapy (CRRT) as a result of the clinical management of the patient (i.e. CRRT is not initiated for the purpose of this study).

• Patient is receiving peramivir for a positive rapid antigen test for influenza or on the basis of clinical suspicion with a high local epidemiological prevalence of H1N1 disease.

• Patient has a CRRT blood flow rate greater than or equal to 100 mL/min with an ultrafiltrate +/- dialysis flow rate greater than or equal to 3000mL/hr,

• The patient is anticipated to require CRRT and peramivir treatment for a full 24 hours (i.e. life expectancy is not less than 24 hours).

Exclusion Criteria

• The patient has received greater than 5 doses of peramivir.

• The subject has a pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.

• The patient is receiving CRRT utilizing a pre-membrane dilution method.

Related Conditions & MeSH terms

• Influenza
• Renal Failure
• Renal Insufficiency

Locations

Country	Name	City	State
United States	Midwestern University/Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Midwestern University	BioCryst Pharmaceuticals, Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be to determine the sieving coefficient for peramivir.		upon study completion (estimated 2 yrs)
Secondary	Determine the extracorporeal clearance for peramivir		upon study completion (estimated 2 yrs)