Phase 4
N=8
Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
End-Stage Renal Disease · Stage 5 Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT02392208 ↗Enrolled (actual)
8
Serious AEs
12.5%
Results posted
Mar 2017
Primary outcome: Primary: Cmax of Telavancin — 33.1; 38.1 mcg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Telavancin (Drug); Pharmacokinetic Blood Sampling (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Telavancin |
33.1; 38.1 | — |
| PRIMARY Vss of Telavancin |
201; 172 | — |
| PRIMARY CLobs of Telavancin |
11.8; 6.1 | — |
| PRIMARY t1/2 of Telavancin |
13.4; 21.4 | — |
| SECONDARY AUC0-24 of Telavancin |
307; 465 | — |
| SECONDARY AUC24-48 of Telavancin |
121; 220 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT02392208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.