A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment
1 other identifier
interventional
48
1 country
1
Brief Summary
This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and female subjects with normal and impaired renal function. The study will be composed of five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 26, 2016
August 1, 2016
5 months
February 26, 2016
August 25, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
plasma concentrations (Cmax)
48 hrs
Tmax The elimination half-life (t1/2),
48 hrs
Secondary Outcomes (2)
Number of Participants With Abnormal Laboratory Values
14 days
Number of Participants With Adverse Events
14 days
Study Arms (1)
FEP-TAZ
EXPERIMENTALCefepime and Tazobactam combination; IV infusion over a period of 90 minutes Healthy subjects, Mild and Moderate RI: 4 g (2 g FEP and 2 g TAZ) Severe RI and patients on HD: 2 g (1 g FEP and 1 g TAZ)
Interventions
Eligibility Criteria
You may qualify if:
- Patients with renal impairment: mild, moderate, severe and patients on hemodialysis) that has been stable OR
- Healthy Subjects:
- Have normal renal function
- No evidence of any disease or condition that may affect pharmacokinetics of FEP-TAZ.
You may not qualify if:
- Evidence of hepatorenal or nephritic syndrome
- Any clinically significant abnormal findings on medical history, physical examination,or clinical laboratory tests (other than those associated with controlled diabetes,hypertension, hypercholesterolemia, dyslipidemia, or renal impairment or related or causative diseases)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami,Division of Clinical Pharmacology
Miami, Florida, 33136, United States
Related Publications (1)
Preston RA, Mamikonyan G, Mastim M, Garg D, Kemper CJ, Xu A, Yeole R, Chavan R, Friedland HD, Bhatia A. Single-Center Investigation of the Pharmacokinetics of WCK 4282 (Cefepime-Tazobactam Combination) in Renal Impairment. Antimicrob Agents Chemother. 2019 Sep 23;63(10):e00873-19. doi: 10.1128/AAC.00873-19. Print 2019 Oct.
PMID: 31332068DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2016
First Posted
March 16, 2016
Study Start
March 1, 2016
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 26, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share