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

University of Michigan

Status and phase: Completed; Phase 4

Conditions: End-Stage Renal Disease; Stage 5 Chronic Kidney Disease

Treatments: Drug: Telavancin; Procedure: Pharmacokinetic Blood Sampling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02392208

HUM00095470

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Telavancin Before Hemodialysis

Other group

Description:

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

Treatment:

Procedure: Pharmacokinetic Blood Sampling

Drug: Telavancin

Telavancin After Hemodialysis

Other group

Description:

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

Treatment:

Procedure: Pharmacokinetic Blood Sampling

Drug: Telavancin