Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5

Phase 4

Completed

• Conditions: End-Stage Renal Disease; Stage 5 Chronic Kidney Disease
• Interventions: Drug: Telavancin; Procedure: Pharmacokinetic Blood Sampling

• Registration Number: NCT02392208
• Lead Sponsor: University of Michigan

Brief Summary

Chronic Kidney Disease Stage 5 (CKD5) patients receiving maintenance hemodialysis are at an increased risk for developing bloodstream infections. Vancomycin is traditionally used as first-line therapy for treating these infections, but the emergence of less-susceptible bacterial strains necessitates the consideration of alternative antibiotic therapy. Telavancin is a new antibiotic that has broad-spectrum antimicrobial activity against gram-positive bacteria, including vancomycin-intermediate staphylococcus aureus. While dosing recommendations for telavancin are available for patients with normal kidney function, there are no published recommendations for CKD5 patients receiving hemodialysis. A pharmacokinetic study is needed to characterize the pharmacokinetic parameters of telavancin in these patients to determine the extent of drug removal by hemodialysis and to establish dosing recommendations for CKD5 patients on maintenance hemodialysis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-18
• Study Start: 2015-07
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2017-01-18
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-08
• Last Update Submitted: 2017-03-29
• Results First Posted: 2017-03-30
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• ≥ 18 years of age
• Within 50 - 150 % of ideal body weight and greater than 40 kg
• CKD5 receiving maintenance hemodialysis for ≥ 3 months
• Creatinine Clearance estimate < 10 mL/min
• Not received telavancin within the past month
• No concurrent illness or evidence of infection
• Able to give informed consent

Exclusion Criteria

• Pre-study Hemoglobin < 9.0 g/dL
• Plasma Albumin < 2.5 g/dL
• Pregnancy
• Breastfeeding
• QTc interval > 470 msec on EKG obtained within the last 6 months
• Receiving concomitant QT prolonging agents
• Receiving warfarin or low molecular weight heparin products
• Known allergy to telavancin or vancomycin
• Unstable blood pressure control
• Need for routine large fluid removal during dialysis (> 4 liters)
• Diagnosis of liver disease with a Child Pugh score of C or higher
• Dialysis isolation requirements due to Hepatitis B
• Participating concurrently in another investigational drug study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Telavancin Before Hemodialysis	Telavancin	Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session.
Telavancin Before Hemodialysis	Pharmacokinetic Blood Sampling	Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session.
Telavancin After Hemodialysis	Pharmacokinetic Blood Sampling	Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.
Telavancin After Hemodialysis	Telavancin	Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.

Primary Outcome Measures

Name	Time	Method
Cmax of Telavancin	At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48	Peak concentration of telavancin
Vss of Telavancin	At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48	Volume of distribution of telavancin at steady state
CLobs of Telavancin	At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48	Observed clearance of telavancin
t1/2 of Telavancin	At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48	Half-life of telavancin

Secondary Outcome Measures

Name	Time	Method
AUC0-24 of Telavancin	At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48	Area under the telavancin concentration-time curve 0-24 hours from start of infusion
AUC24-48 of Telavancin	At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48	Area under the telavancin concentration-time curve 24-48 hours from start of infusion

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States