Conditions: End-stage Renal Disease Cardiovascular Disease
Keywords: ranolazine end-stage renal disease pharmacokinetics cardiovascular disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 17
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.

Interventions: intervention 1: Ranolazine intervention 2: Pharmacokinetic Blood and Dialysate Sampling intervention 3: QT Interval
Intervention descriptions: intervention 1: A single dose of two oral ranolazine extended release 500 mg tablets intervention 2: Blood samples collected to assess ranolazine plasma and dialysate concentrations. intervention 3: Calculation of a QT interval will be performed throughout subject participation.

Protocol document: