At a glance
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Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
In Brief
A Phase 4 clinical trial evaluating Ranolazine, Pharmacokinetic Blood and Dialysate Sampling, and 1 other intervention for End-stage Renal Disease and Cardiovascular Disease. Completed, enrolled 17 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
A single dose of two oral ranolazine extended release 500 mg tablets
Blood samples collected to assess ranolazine plasma and dialysate concentrations.
Calculation of a QT interval will be performed throughout subject participation.