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

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ClinicalTrials.gov Identifier: NCT02392208
Recruitment Status : Completed
First Posted : March 18, 2015
Results First Posted : March 30, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
Theravance Biopharma
Information provided by (Responsible Party):
Bruce A. Mueller, 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.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Stage 5 Chronic Kidney Disease Drug: Telavancin Procedure: Pharmacokinetic Blood Sampling Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
Study Start Date : July 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Vibativ

Procedure: Pharmacokinetic Blood Sampling
Blood samples are collected to assess telavancin plasma concentrations.
Other Name: PK Sampling

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 Name: Vibativ

Procedure: Pharmacokinetic Blood Sampling
Blood samples are collected to assess telavancin plasma concentrations.
Other Name: PK Sampling




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392208


Locations
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United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Theravance Biopharma
Investigators
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Principal Investigator: Bruce A. Mueller, PharmD University of Michigan

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Responsible Party: Bruce A. Mueller, Professor and Associate Dean of Academic Affairs, College of Pharmacy, University of Michigan
ClinicalTrials.gov Identifier: NCT02392208     History of Changes
Other Study ID Numbers: HUM00095470
First Posted: March 18, 2015    Key Record Dates
Results First Posted: March 30, 2017
Last Update Posted: April 4, 2017
Last Verified: March 2017
Keywords provided by Bruce A. Mueller, University of Michigan:
telavancin
end-stage renal disease
ESRD
pharmacokinetics
hemodialysis
chronic kidney disease
CKD
dialysis
Vibativ
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Telavancin
Anti-Bacterial Agents
Anti-Infective Agents