search
Back to results

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

Primary Purpose

End-Stage Renal Disease, Stage 5 Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Telavancin
Pharmacokinetic Blood Sampling
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End-Stage Renal Disease focused on measuring telavancin, end-stage renal disease, ESRD, pharmacokinetics, hemodialysis, chronic kidney disease, CKD, dialysis, Vibativ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Telavancin Before Hemodialysis

Telavancin After Hemodialysis

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cmax of Telavancin
Peak concentration of telavancin
Vss of Telavancin
Volume of distribution of telavancin at steady state
CLobs of Telavancin
Observed clearance of telavancin
t1/2 of Telavancin
Half-life of telavancin

Secondary Outcome Measures

AUC0-24 of Telavancin
Area under the telavancin concentration-time curve 0-24 hours from start of infusion
AUC24-48 of Telavancin
Area under the telavancin concentration-time curve 24-48 hours from start of infusion

Full Information

First Posted
March 12, 2015
Last Updated
March 29, 2017
Sponsor
University of Michigan
Collaborators
Theravance Biopharma
search

1. Study Identification

Unique Protocol Identification Number
NCT02392208
Brief Title
Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
Official Title
Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Theravance Biopharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease, Stage 5 Chronic Kidney Disease
Keywords
telavancin, end-stage renal disease, ESRD, pharmacokinetics, hemodialysis, chronic kidney disease, CKD, dialysis, Vibativ

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telavancin Before Hemodialysis
Arm Type
Other
Arm Description
Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session.
Arm Title
Telavancin After Hemodialysis
Arm Type
Other
Arm Description
Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.
Intervention Type
Drug
Intervention Name(s)
Telavancin
Other Intervention Name(s)
Vibativ
Intervention Description
A single 5 mg/kg dose of telavancin is administered intravenously (IV).
Intervention Type
Procedure
Intervention Name(s)
Pharmacokinetic Blood Sampling
Other Intervention Name(s)
PK Sampling
Intervention Description
Blood samples are collected to assess telavancin plasma concentrations.
Primary Outcome Measure Information:
Title
Cmax of Telavancin
Description
Peak concentration of telavancin
Time Frame
At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Title
Vss of Telavancin
Description
Volume of distribution of telavancin at steady state
Time Frame
At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Title
CLobs of Telavancin
Description
Observed clearance of telavancin
Time Frame
At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Title
t1/2 of Telavancin
Description
Half-life of telavancin
Time Frame
At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Secondary Outcome Measure Information:
Title
AUC0-24 of Telavancin
Description
Area under the telavancin concentration-time curve 0-24 hours from start of infusion
Time Frame
At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Title
AUC24-48 of Telavancin
Description
Area under the telavancin concentration-time curve 24-48 hours from start of infusion
Time Frame
At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce A. Mueller, PharmD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34613416
Citation
Gharibian KN, Lewis SJ, Heung M, Segal JH, Salama NN, Mueller BA. Telavancin pharmacokinetics in patients with chronic kidney disease receiving haemodialysis. J Antimicrob Chemother. 2021 Dec 24;77(1):174-180. doi: 10.1093/jac/dkab370.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs