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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

End-stage Renal Disease Cardiovascular Disease Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) < 10 mL/min
No concurrent illness or evidence of infection
Able to give informed consent

Exclusion criteria

QTc interval > 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 < 9.5 g/dL
Plasma albumin < 2.5 g/dL
Liver disease - exclude subjects with a Child Pugh score of C or higher
Positive pregnancy test
Breastfeeding
Allergy to ranolazine
Participating in another investigational study
Hepatitis B infection due to dialysis isolation requirements
Unstable blood pressure control
Need for routine large fluid removal during dialysis (> 4L)

Treatment and study plan

Ranolazine

Drug

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

Other names: Ranexa

pharmacokinetic blood and dialysate sampling

Procedure

Blood samples collected to assess ranolazine plasma and dialysate concentrations.

Other names: Ranexa, PK sampling

QT Interval

Procedure

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

Other names: Ranexa, QT interval calculation

Primary outcomes

Pharmacokinetic Parameters of Ranolazine

Time frame: At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65

Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

Gilead Sciences

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Sep 16, 2011
Registry last updated: Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed