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

Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End-Stage Renal Disease; Stage 5 Chronic Kidney Disease

Intervention: Telavancin (Drug); Pharmacokinetic Blood Sampling (Procedure)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Michigan

Official(s) and/or principal investigator(s):
Bruce A. Mueller, PharmD, Principal Investigator, Affiliation: University of Michigan

Overall contact:
Bruce A. Mueller, PharmD, Phone: (734) 615-4578, Email: muellerb@med.umich.edu

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Pharmacokinetic Parameters of Telavancin

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Bruce A. Mueller, PharmD, Phone: (734) 615-4578, Email: muellerb@med.umich.edu

University of Michigan Hospital, Ann Arbor, Michigan 48109, United States; Recruiting
Bruce A Mueller, Principal Investigator
Additional Information

Starting date: July 2015
Last updated: July 7, 2015

Page last updated: August 23, 2015

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