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COMPLETEDPhase 4NCT01435174

Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients

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 wi...

Lead sponsor: University of Michigan•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Michigan

Collaborators

Gilead Sciences

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

No

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)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 16, 2017Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment17

Start dateOct 2011

Last updatedOct 16, 2017

Condition

End-stage Renal Disease Cardiovascular Disease

Locations shown

University of Michigan Hospital

Ann Arbor, Michigan

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 16, 2017Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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