End-stage Renal DiseasePhase 4NCT01435174
Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
A Phase 4 study testing Ranolazine, Pharmacokinetic Blood and Dialysate Sampling and QT Interval in people with End-stage Renal Disease and Cardiovascular Disease, run by University of Michigan at 1 site in United States.
Trial 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 without reducing heart rate or blood pressure makes it an important option for ESRD patients. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- End-stage Renal Disease, Cardiovascular Disease
- What is being tested?
- Ranolazine, Pharmacokinetic Blood and Dialysate Sampling and QT Interval
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Mar 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
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.
- Conditions
- End-stage Renal Disease, Cardiovascular Disease
- Being tested
- Ranolazine, Pharmacokinetic Blood and Dialysate Sampling, QT Interval
- Keywords
- ranolazine, end-stage renal disease, pharmacokinetics, cardiovascular disease
- Medical subject headings
- Kidney Failure, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called Ranexa
A single dose of two oral ranolazine extended release 500 mg tablets
Pharmacokinetic Blood and Dialysate SamplingProcedure or surgery
Also called Ranexa, PK sampling
Blood samples collected to assess ranolazine plasma and dialysate concentrations.
QT IntervalProcedure or surgery
Also called Ranexa, QT interval calculation
Calculation of a QT interval will be performed throughout subject participation.
| Study group | Role | What they receive |
|---|---|---|
| Ranolazine | Experimental | End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session. Receives: Drug: Ranolazine; Procedure: Pharmacokinetic Blood and Dialysate Sampling; Procedure: QT Interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameters of Ranolazine
Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine
Measured: At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Bruce A. Mueller, University of Michigan
- Investigators
- Bruce A Mueller, PharmD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435174
- Sponsor's protocol ID
- IN-US-259-0123, HUM00051141
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2011
- Last updated
- 16 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30909832
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01435174
- Acronym / sponsor ID
- IN-US-259-0123, HUM00051141
- Conditions
- End-stage Renal Disease, Cardiovascular Disease
- Keywords
- ranolazine, end-stage renal disease, pharmacokinetics, cardiovascular disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Oct 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Sep 2011 (estimated)
- Results
- Posted 25 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranolazine | Experimental | Drug: Ranolazine, Procedure: Pharmacokinetic Blood and Dialysate Sampling, Procedure: QT IntervalEnd-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanolazineAlso: RanexaA single dose of two oral ranolazine extended release 500 mg tablets | Drug | Ranolazine |
| Pharmacokinetic Blood and Dialysate SamplingAlso: Ranexa, PK samplingBlood samples collected to assess ranolazine plasma and dialysate concentrations. | Procedure or surgery | Ranolazine |
| QT IntervalAlso: Ranexa, QT interval calculationCalculation of a QT interval will be performed throughout subject participation. | Procedure or surgery | Ranolazine |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30909832Scoville 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce A Mueller, PharmD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranolazine, Pharmacokinetic Blood and Dialysate Sampling and QT Interval in people with End-stage Renal Disease and Cardiovascular Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Parameters of Ranolazine (time frame: At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01435174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.