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Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients

NCT01435174 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-10-16

Study results available
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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.

Conditions

Interventions

DRUG

Ranolazine

A single dose of two oral ranolazine extended release 500 mg tablets

PROCEDURE

Pharmacokinetic Blood and Dialysate Sampling

Blood samples collected to assess ranolazine plasma and dialysate concentrations.

PROCEDURE

QT Interval

Calculation of a QT interval will be performed throughout subject participation.

Sponsors & Collaborators

Principal Investigators

  • Bruce A Mueller, PharmD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01435174 on ClinicalTrials.gov