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
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Condition or disease | Intervention/treatment | Phase |
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End-stage Renal Disease Cardiovascular Disease | Drug: Ranolazine Procedure: Pharmacokinetic Blood and Dialysate Sampling Procedure: QT Interval | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
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Experimental: Ranolazine
End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
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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:
Procedure: QT Interval Calculation of a QT interval will be performed throughout subject participation.
Other Names:
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- 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

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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 |
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)

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
United States, Michigan | |
University of Michigan Hospital | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Bruce A Mueller, PharmD | University of Michigan |
Responsible Party: | Bruce A. Mueller, Associate Dean of Academic Affairs, University of Michigan |
ClinicalTrials.gov Identifier: | NCT01435174 |
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 |
ranolazine end-stage renal disease pharmacokinetics cardiovascular disease |
Kidney Diseases Kidney Failure, Chronic Cardiovascular Diseases Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
Ranolazine Dialysis Solutions Pharmaceutical Solutions Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |