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

End-Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392208
• Other study ID #: HUM00095470
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2015
• Last updated: March 29, 2017
• Start date: July 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic
• Stage 5 Chronic Kidney Disease

Intervention

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

Procedure:
• Pharmacokinetic Blood Sampling
Blood samples are collected to assess telavancin plasma concentrations.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Theravance Biopharma Antibiotics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of Telavancin	Peak concentration of telavancin	At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Primary	Vss of Telavancin	Volume of distribution of telavancin at steady state	At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Primary	CLobs of Telavancin	Observed clearance of telavancin	At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Primary	t1/2 of Telavancin	Half-life of telavancin	At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Secondary	AUC0-24 of Telavancin	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
Secondary	AUC24-48 of Telavancin	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