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

March 29, 2017 updated by: Bruce A. Mueller, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Telavancin Before Hemodialysis
Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session.
Drug: Telavancin
A single 5 mg/kg dose of telavancin is administered intravenously (IV).
Other Names:
  • Vibativ
Procedure: Pharmacokinetic Blood Sampling
Blood samples are collected to assess telavancin plasma concentrations.
Other Names:
  • PK Sampling
Other: Telavancin After Hemodialysis
Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.
Drug: Telavancin
A single 5 mg/kg dose of telavancin is administered intravenously (IV).
Other Names:
  • Vibativ
Procedure: Pharmacokinetic Blood Sampling
Blood samples are collected to assess telavancin plasma concentrations.
Other Names:
  • PK Sampling

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-24 of Telavancin
Time Frame: 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
At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
AUC24-48 of Telavancin
Time Frame: 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
At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Theravance Biopharma

Investigators

  • Principal Investigator: Bruce A. Mueller, PharmD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 12, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00095470

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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