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NCT03612180 · ClinicalTrials.gov registry record
Evaluation of Metoprolol Pharmacokinetics in Patients Receiving Hi Flux Hemodialysis
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 8
- Enrollment target
NCT03612180: Completed study, sponsored by University of Michigan.
NCT03612180 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03612180 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
Characterize the pharmacokinetics of metoprolol and its metabolite, alpha-hydroxymetoprolol during and after HD
Interventions
- DRUG Metoprolol Succinate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-06-30 |
| Est. Completion | 2019-05-31 |
What the finished NCT03612180 record still lists
NCT03612180 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Metoprolol Succinate is the first listed.
NCT03612180 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03612180 about?
NCT03612180 is a clinical study titled "Evaluation of Metoprolol Pharmacokinetics in Patients Receiving Hi Flux Hemodialysis". 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 t...
What is the current status of trial NCT03612180?
This trial is currently completed. The enrollment target is 8 participants. The study started on 2018-06-30. Estimated completion is 2019-05-31.
What interventions are being tested in trial NCT03612180?
The interventions under investigation include: Metoprolol Succinate (DRUG).
Who is sponsoring clinical trial NCT03612180?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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