Phase 4 N=17 Treatment

Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients

End-stage Renal Disease · Cardiovascular Disease

Bottom Line

View on ClinicalTrials.gov: NCT01435174 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Jun 2014

Primary outcome: Primary: Pharmacokinetic Parameters of Ranolazine — 0.65 mcg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ranolazine (Drug); Pharmacokinetic Blood and Dialysate Sampling (Procedure); QT Interval (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetic Parameters of Ranolazine	0.65	—

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.

Eligibility 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) 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 4L)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01435174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.