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Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT01435174
Recruitment Status : Completed
First Posted : September 16, 2011
Results First Posted : June 25, 2014
Last Update Posted : October 16, 2017
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Bruce A. Mueller, University of Michigan

Study Description
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Brief Summary:
End-stage renal disease (ESRD) patients often develop cardiovascular complications, and cardiovascular disease is the leading cause of death in this population. Ranolazine's ability to treat angina without reducing heart rate or blood pressure makes it an important option for ESRD patients. The hemodialysis clearance of ranolazine is unknown. A single-dose pharmacokinetic study is needed to characterize ranolazine and its metabolites in ESRD patients on and off hemodialysis. Results of the proposed study will provide initial dosing estimates for a follow-up, multiple-dose pharmacokinetic study in this population.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Cardiovascular Disease Drug: Ranolazine Procedure: Pharmacokinetic Blood and Dialysate Sampling Procedure: QT Interval Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
Study Start Date : October 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ranolazine
End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
 Drug: Ranolazine
A single dose of two oral ranolazine extended release 500 mg tablets
Other Name: Ranexa

Procedure: Pharmacokinetic Blood and Dialysate Sampling
Blood samples collected to assess ranolazine plasma and dialysate concentrations.
Other Names:
  • Ranexa
  • PK sampling

Procedure: QT Interval
Calculation of a QT interval will be performed throughout subject participation.
Other Names:
  • Ranexa
  • QT interval calculation


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic Parameters of Ranolazine [ Time Frame: At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65 ]
    Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-74 years of age
  • Within 50% of ideal body weight and greater than 40 kg
  • Chronic kidney disease (CKD) stage 5 receiving maintenance hemodialysis for at least 3 months
  • Native kidney estimated glomerular filtration rate(GFR) < 10 mL/min
  • No concurrent illness or evidence of infection
  • Able to give informed consent

Exclusion Criteria:

  • QTc interval > 470 msec at echocardiogram (ECG) obtained within the last 6 months
  • Concomitant QT-prolonging drugs, major P-gp inhibitors, and CYP3A4 inducers and inhibitors including: cyclosporine, rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, St. John's Wort, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, saquinavir, quinidine, dofetilide, sotalol, amiodarone, erythromycin, thioridazine, ziprasidone, haloperidol, trimethoprim/sulfamethoxazole, ciprofloxacin, norfloxacin, levofloxacin, moxifloxacin
  • Pre-study hemoglobin < 9.5 g/dL
  • Plasma albumin < 2.5 g/dL
  • Liver disease - exclude subjects with a Child Pugh score of C or higher
  • Positive pregnancy test
  • Breastfeeding
  • Allergy to ranolazine
  • Participating in another investigational study
  • Hepatitis B infection due to dialysis isolation requirements
  • Unstable blood pressure control
  • Need for routine large fluid removal during dialysis (> 4L)
Contacts and Locations
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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): NCT01435174


Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Gilead Sciences
Investigators
Principal Investigator: Bruce A Mueller, PharmD University of Michigan
More Information
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Responsible Party: Bruce A. Mueller, Associate Dean of Academic Affairs, University of Michigan
ClinicalTrials.gov Identifier: NCT01435174     History of Changes
Other Study ID Numbers: IN-US-259-0123, HUM00051141
First Posted: September 16, 2011    Key Record Dates
Results First Posted: June 25, 2014
Last Update Posted: October 16, 2017
Last Verified: September 2017

Keywords provided by Bruce A. Mueller, University of Michigan:
ranolazine
end-stage renal disease
pharmacokinetics
cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
 Dialysis Solutions
Ranolazine
Pharmaceutical Solutions
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action