Status:
COMPLETED
Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Gilead Sciences
Conditions:
End-stage Renal Disease
Cardiovascular Disease
Eligibility:
All Genders
18-74 years
Phase:
PHASE4
Brief 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 wi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01435174
Start Date
October 1 2011
End Date
March 1 2013
Last Update
October 16 2017
Active Locations (1)
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1
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109