Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2015 |
| End Date: | March 2016 |
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.
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.
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
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