A Phase 4 interventional study of Ranolazine and Pharmacokinetic Blood and Dialysate Sampling in End-stage Renal Disease and Cardiovascular Disease, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2017-10-16.
Sponsored by University of Michigan · Phase 4, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 17 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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Exclusion Criteria:
End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
Drug: Ranolazine · Procedure: Pharmacokinetic Blood and Dialysate Sampling · Procedure: QT Interval
A single dose of two oral ranolazine extended release 500 mg tablets
Also known as: Ranexa
Blood samples collected to assess ranolazine plasma and dialysate concentrations.
Also known as: Ranexa, PK sampling
Calculation of a QT interval will be performed throughout subject participation.
Also known as: Ranexa, QT interval calculation
Pharmacokinetic Parameters of Ranolazine
Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine
Time frame: At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65
| Milestone | Ranolazine |
|---|---|
| Started | 17 |
| Completed | 8 |
| Not completed | 9 |
Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine
| mcg/mL | Ranolazine |
|---|---|
| Pharmacokinetic Parameters of Ranolazine | 0.65 ± 0.27 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ranolazine | — | 1/8 (12.5%) | 0/8 (0%) |
| Event | Ranolazine |
|---|---|
| Elevated Potassium with EKG ChangesCardiac disorders | 1/8 |
Patients 18 to 74 with chronic kidney disease stage 5 receiving 3 times weekly maintenance hemodialysis for at least 3 months were considered for study inclusion. Patients had to weigh \>40 kilograms, be within 50-150% of their ideal body weight, have an eGFR of \<10 mL/min, have no evidence of infection, and be able to give informed consent.
| Age, Continuous(years) | Ranolazine |
|---|---|
| Median | 33 (20 to 63) |
| Age, Categorical(Participants) | Ranolazine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Ranolazine |
|---|---|
| Female | 8 |
| Male | 9 |
| Region of Enrollment(participants) | Ranolazine |
|---|---|
| United States | 17 |
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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