Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
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.
End-stage Renal Disease
Procedure: Pharmacokinetic Blood and Dialysate Sampling
Procedure: QT Interval
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients|
- Pharmacokinetic Parameters of Ranolazine [ Time Frame: At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65 ] [ Designated as safety issue: No ]Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine
- QT Interval [ Time Frame: At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30 ] [ Designated as safety issue: Yes ]Calculation of the QT interval after receiving a single-dose of ranolazine
|Study Start Date:||October 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
A single dose of two oral ranolazine extended release 500 mg tablets
Other Name: RanexaProcedure: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435174
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Bruce A Mueller, PharmD||University of Michigan|