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Evaluation of Amlodipine Pharmacokinetics in Patients Receiving Hi Flux Hemodialysis

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ClinicalTrials.gov Identifier: NCT03722381
Recruitment Status : Not yet recruiting
First Posted : October 26, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Amy Barton Pai, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment
Hemodialysis Pharmacokinetics Drug: Amlodipine Besylate

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Study Type : Observational
Estimated Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Amlodipine Pharmacokinetics in Patients Receiving Hi Flux Hemodialysis
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis


Intervention Details:
  • Drug: Amlodipine Besylate
    Pharmacokinetics


Primary Outcome Measures :
  1. Use pharmacokinetics to characterize the plasma concentration of amlodipine and its metabolite, 2-([4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl- 2-pyridyl]methoxy) acetic acid [ Time Frame: Pre-dialysis, during dialysis (30 minutes, 2 hours, end of treatment) and post-dialysis (30 minutes, 2 hours and 4 hours) ]
    Use pharmacokinetics to characterize the change in plasma concentration of amlodipine and its metabolite, 2-([4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl- 2-pyridyl]methoxy) acetic acid during and after HD


Secondary Outcome Measures :
  1. Characterize the Non-renal clearance phenotype and genotype [ Time Frame: 30 minutes ]
    Evaluate the non-renal clearance of amlodipine in patients on HD.

  2. Characterize the Post-dialysis Rebound [ Time Frame: post-dialysis (30 minutes, 2 hours and 4 hours) ]
    Simulate change in predicted rebound of metoprolol concentrations



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ambulatory in-center hemodialysis patients
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Indwelling tunneled catheter, AVF, AVG that is currently used for hemodialysis
  3. Receiving in-center hemodialysis 3 days a week for 3-4.5 hours each treatment
  4. Taking a total daily dose of 5-10 mg of amlodipine as prescribed by their physician
  5. Hemoglobin ≥ 9.5 g/dL on most recent laboratory assessment prior to study

Exclusion Criteria:

  1. Any condition that would not allow for arm BP to be taken
  2. Hemoglobin < 9.5 g/dL on most recent lab prior to study
  3. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722381


Contacts
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Contact: Amy Pai, PharmD 7346470005 amypai@med.umich.edu

Locations
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United States, Michigan
University of Michigan Dialysis Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Amy Pai, PharmD    734-647-0005    amypai@med.umich.edu   
Sponsors and Collaborators
University of Michigan

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Responsible Party: Amy Barton Pai, Amy Pai, PharmD Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03722381     History of Changes
Other Study ID Numbers: HUM00143303
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents