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Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
This study has been completed.
Sponsor:
University of Michigan
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Bruce A. Mueller, University of Michigan
ClinicalTrials.gov Identifier:
NCT01435174
First received: September 14, 2011
Last updated: June 24, 2014
Last verified: June 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| End-stage Renal Disease Cardiovascular Disease | Drug: Ranolazine Procedure: Pharmacokinetic Blood and Dialysate Sampling Procedure: QT Interval | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients |
Resource links provided by NLM:
Further study details as provided by Bruce A. Mueller, University of Michigan:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- QT Interval [ Time Frame: At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30 ]Calculation of the QT interval after receiving a single-dose of ranolazine
| Enrollment: | 17 |
| Study Start Date: | October 2011 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ranolazine
End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
|
Drug: Ranolazine
A single dose of two oral ranolazine extended release 500 mg tablets
Other Name: Ranexa
Procedure: 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.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 74 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01435174
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435174
Locations
| United States, Michigan | |
| University of Michigan Hospital | |
| Ann Arbor, Michigan, United States, 48109 | |
Sponsors and Collaborators
University of Michigan
Gilead Sciences
Investigators
| Principal Investigator: | Bruce A Mueller, PharmD | University of Michigan |
More Information
| Responsible Party: | Bruce A. Mueller, Associate Dean of Academic Affairs, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01435174 History of Changes |
| Other Study ID Numbers: |
IN-US-259-0123, HUM00051141 |
| Study First Received: | September 14, 2011 |
| Results First Received: | May 21, 2014 |
| Last Updated: | June 24, 2014 |
Keywords provided by Bruce A. Mueller, University of Michigan:
|
ranolazine end-stage renal disease pharmacokinetics cardiovascular disease |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |
Dialysis Solutions Ranolazine Pharmaceutical Solutions Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 21, 2017