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

Withdrawn

• Conditions: Influenza; Renal Failure

• Registration Number: NCT01146353
• Lead Sponsor: Midwestern University

Brief 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.

Detailed Description

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 No patients were enrolled as the peramivir EUA was rescinded.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-17
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be to determine the sieving coefficient for peramivir.	upon study completion (estimated 2 yrs)

Secondary Outcome Measures

Name	Time	Method
Determine the extracorporeal clearance for peramivir	upon study completion (estimated 2 yrs)

Trial Locations

Locations (1)

Midwestern University/Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States