Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03612180
Status:
COMPLETED
Last Update Posted:
2019-07-29
First Post:
2018-07-12
Brief Title:
Evaluation of Metoprolol Pharmacokinetics in Patients Receiving Hi Flux Hemodialysis
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Evaluation of Metoprolol Pharmacokinetics in Patients Receiving Hi Flux Hemodialysis
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current study will evaluate the plasma pharmacokinetics of metoprolol in a cohort of 8 adult volunteers who are receiving regular hemodialysis treatment HD 3 days a week for 4 hours each day and have been taking a total daily dose of 25-200 mg of metoprolol succinate for 30 days as part of their usual care Blood sampling will occur over 10 hours with frequent sampling during HD and in the 4 hours after termination of HD treatment The 8 subjects will all receive their prescribed dose 25-200 mg total daily dose 2 hours prior to HD treatment The pre-HD sample will also be sent for pharmacogenomics genotyping Safety and pharmacodynamic assessments blood pressure BP and heart rate HR assessments will be performed throughout the study Axiom Precision Medicine Research Array Affymetrix Santa Clara CA will be used to evaluate genotype of CYP2D6 CYP2D6 phenotype will be evaluated using the ratio of parent drug to metabolite Non-compartmental analyses will be performed to compare maximum concentrations Cmax time to maximum concentration and area under the curve from time 0 to the last measurable sample AUClast between the two phases Compartmental analyses will be performed to construct a model to explain time-dependent changes in metoprolol clearance Monte Carlo simulations will be performed to compare metoprolol pharmacokinetic profiles on and off HD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None