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NCT02392208 · ClinicalTrials.gov registry record · Phase 4
Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
A Phase 4 study of End Stage Renal Disease and Stage 5 Chronic Kidney Disease, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT02392208 is a Phase 4 study of End Stage Renal Disease and Stage 5 Chronic Kidney Disease that has completed, run by University of Michigan. The registered enrollment target is 8 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02392208, a Phase 4 study of End Stage Renal Disease and Stage 5 Chronic Kidney Disease, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Telavancin
- PROCEDURE Pharmacokinetic Blood Sampling
Study Locations (1)
Michigan
- University of Michigan Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02392208
The ClinicalTrials.gov registry entry for NCT02392208 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (99% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 2 interventions - of which Telavancin is the first listed.
NCT02392208 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT02392208 about?
NCT02392208 is a clinical study titled "Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5". 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...
What is the current status of trial NCT02392208?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2015-07. Estimated completion is 2016-03.
What conditions does trial NCT02392208 study?
This clinical trial studies the following conditions: End Stage Renal Disease, Stage 5 Chronic Kidney Disease.
What interventions are being tested in trial NCT02392208?
The interventions under investigation include: Telavancin (DRUG), Pharmacokinetic Blood Sampling (PROCEDURE).
Who is sponsoring clinical trial NCT02392208?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02392208 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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