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Completed

NCT Number: NCT02392208

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

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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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Stage 5 Chronic Kidney Disease Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telavancin

Drug

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

Other names: Vibativ

pharmacokinetic blood sampling

Procedure

Blood samples are collected to assess telavancin plasma concentrations.

Other names: PK Sampling

Primary outcomes

  1. Cmax of Telavancin

    Time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

    Peak concentration of telavancin

  2. 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

  3. CLobs of Telavancin

    Time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

    Observed clearance of telavancin

  4. t1/2 of Telavancin

    Time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

    Half-life of telavancin

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Theravance Biopharma

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 18, 2015
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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