Evaluation of Amlodipine Pharmacokinetics in Patients Receiving Hi Flux Hemodialysis

Withdrawn before enrolling

Conditions studied: Hemodialysis, Pharmacokinetics

In brief

The current study will evaluate the plasma pharmacokinetics of amlodipine 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 5-10 mg of amlodipine besylate for \>30 days as part of their usual care. Blood sampling will occur over 13 hours, with frequent sampling during HD and in the 4 hours after termination of HD treatment. The 8 subjects will all receive their prescribed total daily dose of 5-10 mg 5 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 CYP3A4. CYP3A4 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 amlodipine clearance. Monte Carlo simulations will be performed to compare amlodipine pharmacokinetic profiles on and off HD.

Key facts

Study ID

NCT03722381

Run by

University of Michigan

People needed

0

Starts

2020-01-01

Expected to finish

2020-01-30

Last updated by the study team

2020-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Indwelling tunneled catheter, AVF, AVG that is currently used for hemodialysis
• Receiving in-center hemodialysis 3 days a week for 3-4.5 hours each treatment
• Taking a total daily dose of 5-10 mg of amlodipine as prescribed by their physician
• Hemoglobin ≥ 9.5 g/dL on most recent laboratory assessment prior to study

You may not qualify if…

• Any condition that would not allow for arm BP to be taken
• Hemoglobin < 9.5 g/dL on most recent lab prior to study
• Patient is on a CYP3A4 inhibitor (most common in HD population include: amiodarone, clarithromycin, cyclosporine, diltiazem, erythromycin, fluconazole, fluoxetine, fluvoxamine, nefazodone, tamoxifen, verapamil, and grapefruit juice).

Where it is running

• University of Michigan Dialysis — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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