Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients

Completed · Phase 4

Conditions studied: End-stage Renal Disease, Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT01435174

Run by

University of Michigan

People needed

17

Starts

2011-10-01

Expected to finish

2013-03-01

Last updated by the study team

2017-10-16

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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