Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 74 |
| Updated: | 10/18/2017 |
| Start Date: | October 2011 |
| End Date: | March 2013 |
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.
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.
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)
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