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Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients

NCT ID: NCT01435174

Last Updated: 2017-10-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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End-stage Renal Disease Cardiovascular Disease

Keywords

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ranolazine end-stage renal disease pharmacokinetics cardiovascular disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ranolazine

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

Group Type EXPERIMENTAL

Ranolazine

Intervention Type DRUG

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

Pharmacokinetic Blood and Dialysate Sampling

Intervention Type PROCEDURE

Blood samples collected to assess ranolazine plasma and dialysate concentrations.

QT Interval

Intervention Type PROCEDURE

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

Interventions

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Ranolazine

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

Intervention Type DRUG

Pharmacokinetic Blood and Dialysate Sampling

Blood samples collected to assess ranolazine plasma and dialysate concentrations.

Intervention Type PROCEDURE

QT Interval

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

Intervention Type PROCEDURE

Other Intervention Names

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Ranexa Ranexa PK sampling Ranexa QT interval calculation

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Bruce A. Mueller

Associate Dean of Academic Affairs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce A Mueller, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Hospital

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Scoville BA, Segal JH, Salama NN, Heung M, Bleske BE, Eyler RF, Mueller BA. Single dose oral ranolazine pharmacokinetics in patients receiving maintenance hemodialysis. Ren Fail. 2019 Nov;41(1):118-125. doi: 10.1080/0886022X.2019.1585371.

Reference Type DERIVED
PMID: 30909832 (View on PubMed)

Other Identifiers

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IN-US-259-0123, HUM00051141

Identifier Type: -

Identifier Source: org_study_id