Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
Condition: End-Stage Renal Disease; Stage 5 Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Intervention: Telavancin; Pharmacokinetic Blood Sampling
Intervention description: A single 5 mg/kg dose of telavancin is administered intravenously (IV).; Blood samples are collected to assess telavancin plasma concentrations.
Intervention MeSH terms: Telavancin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: telavancin; end-stage renal disease; ESRD; pharmacokinetics; hemodialysis; chronic kidney disease; CKD; dialysis; Vibativ

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.
    

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