Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Cmax of Telavancin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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
研究组 & 干预措施
Telavancin Before Hemodialysis
Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session.
干预措施: Telavancin (Drug)
Telavancin Before Hemodialysis
Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session.
干预措施: Pharmacokinetic Blood Sampling (Procedure)
Telavancin After Hemodialysis
Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.
干预措施: Telavancin (Drug)
Telavancin After Hemodialysis
Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.
干预措施: Pharmacokinetic Blood Sampling (Procedure)
结局指标
主要结局
Cmax of Telavancin
时间窗: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Peak concentration of telavancin
Vss of Telavancin
时间窗: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Volume of distribution of telavancin at steady state
CLobs of Telavancin
时间窗: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Observed clearance of telavancin
t1/2 of Telavancin
时间窗: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Half-life of telavancin
次要结局
- AUC24-48 of Telavancin(At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48)
- AUC0-24 of Telavancin(At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48)
研究者
Bruce A. Mueller
Professor and Associate Dean of Academic Affairs, College of Pharmacy
University of Michigan