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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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End-Stage Renal Disease Stage 5 Chronic Kidney Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Telavancin Before Hemodialysis

Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session.

Group Type OTHER

Telavancin

Intervention Type DRUG

A single 5 mg/kg dose of telavancin is administered intravenously (IV).

Pharmacokinetic Blood Sampling

Intervention Type PROCEDURE

Blood samples are collected to assess telavancin plasma concentrations.

Telavancin After Hemodialysis

Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.

Group Type OTHER

Telavancin

Intervention Type DRUG

A single 5 mg/kg dose of telavancin is administered intravenously (IV).

Pharmacokinetic Blood Sampling

Intervention Type PROCEDURE

Blood samples are collected to assess telavancin plasma concentrations.

Interventions

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Telavancin

A single 5 mg/kg dose of telavancin is administered intravenously (IV).

Intervention Type DRUG

Pharmacokinetic Blood Sampling

Blood samples are collected to assess telavancin plasma concentrations.

Intervention Type PROCEDURE

Other Intervention Names

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Vibativ PK Sampling

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No