HemodialysisPHASENCT01650012
Eplerenone in Hemodialysis Trial
A study testing eplerenone in people with Hemodialysis and End Stage Renal Disease, run by McMaster University at 5 sites in Canada.
Trial summary
Forty percent of patients that require dialysis for kidney failure die within three years mostly due to heart disease. Heart failure and high blood pressure are common problems in patients that require dialysis and are key causes of death due to heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, End Stage Renal Disease
- What is being tested?
- eplerenone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 5 sitesCanada
- Study dates
- Mar 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- On hemodialysis >90 days
- Prescribed target body weight within 1 kg of current for all dialysis sessions within 4 weeks prior to randomization
- Able to provide written informed consent to participate
Who cannot join
- Occurrence of documented clinically important hypotension (systolic blood pressure <90 that required treatment) within 4 weeks of randomization
- Change in blood pressure medications within 4 weeks prior to randomization
- Occurrence of pre-dialysis serum potassium >6.0 mmol/L in 4 weeks prior to randomization
- Currently treated with and cannot withdraw spironolactone or eplerenone due to medical necessity
- Known allergy or sensitivity to eplerenone
- Pregnancy
- Scheduled living related donor renal transplant within the next 6 months
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Study site
Calgary, Alberta
St. Joseph's Healthcare
Hamilton, Ontario
Study site
London, Ontario
St. Michael's Hospital
Toronto, Ontario
Study site
Winnipeg, Manitoba
About this study
Official title: Pilot Trial of Hemodialysis Patient Aldosterone antagoniSm With Eplerenone Trial
Forty percent of patients that require dialysis for kidney failure die within three years mostly due to heart disease. Heart failure and high blood pressure are common problems in patients that require dialysis and are key causes of death due to heart disease. Eplerenone is a drug that is very effective at improving heart failure and reducing blood pressure in patients that do not require dialysis. There is currently no evidence to tell physicians whether eplerenone would have similar benefits in patients that require dialysis. This evidence can only be reliably generated by performing a large scale study. Before such a study is undertaken, the investigators must determine whether eplerenone will be well tolerated and safe in patients that require dialysis. The investigators will perform an initial small trial called the Pilot trial in Hemodialysis patients undergoing Aldosterone antagoniSm with Eplerenone (PHASE) to determine if eplerenone is a well tolerated, safe medication to use in a very large, global study that will show whether or not eplerenone reduces important outcomes for patients like death from heart causes.
- Conditions
- Hemodialysis, End Stage Renal Disease
- Being tested
- eplerenone, Placebo
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eplerenoneDrug
target 50 mg per day titrated down for hyperkalemia or hypotension
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Eplerenone | Experimental | Target of 50 mg/day Receives: Drug: eplerenone |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension
Measured: 13 weeks
Secondary outcomes (6)
permanent discontinuation of study drug for any reason
Measured: 13 weeks
treatment adherence
Measured: 13 weeks
pre-dialysis potassium
Measured: 13 weeks
frequency of serious adverse events
Measured: 13 weeks
frequency of hospitalizations for a vascular reason
Measured: 13 weeks
fatal and non-fatal vascular events
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Michael Walsh, Principal investigator, McMaster University, Population Health Research Institute, St. Joseph's HospitalRon Wald, Principal investigator, Keenan Research Centre, St. Michael's Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650012
- Sponsor's protocol ID
- PHASE-1
- Acronym
- PHASE
- Status last verified
- Sep 2015
- First submitted
- 23 Jul 2012
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
PubMed 33586138
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Hemodialysis Patient Aldosterone antagoniSm With Eplerenone Trial
- ClinicalTrials.gov ID
- NCT01650012
- Acronym / sponsor ID
- PHASE / PHASE-1
- Conditions
- Hemodialysis, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Forty percent of patients that require dialysis for kidney failure die within three years mostly due to heart disease. Heart failure and high blood pressure are common problems in patients that require dialysis and are key causes of death due to heart disease. Eplerenone is a drug that is very effective at improving heart failure and reducing blood pressure in patients that do not require dialysis. There is currently no evidence to tell physicians whether eplerenone would have similar benefits in patients that require dialysis. This evidence can only be reliably generated by performing a large scale study. Before such a study is undertaken, the investigators must determine whether eplerenone will be well tolerated and safe in patients that require dialysis. The investigators will perform an initial small trial called the Pilot trial in Hemodialysis patients undergoing Aldosterone antagoniSm with Eplerenone (PHASE) to determine if eplerenone is a well tolerated, safe medication to use in a very large, global study that will show whether or not eplerenone reduces important outcomes for patients like death from heart causes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eplerenone | Experimental | Drug: eplerenoneTarget of 50 mg/day |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- On hemodialysis >90 days
- Prescribed target body weight within 1 kg of current for all dialysis sessions within 4 weeks prior to randomization
- Able to provide written informed consent to participate
Key exclusion criteria (7 listed)
- Occurrence of documented clinically important hypotension (systolic blood pressure <90 that required treatment) within 4 weeks of randomization
- Change in blood pressure medications within 4 weeks prior to randomization
- Occurrence of pre-dialysis serum potassium >6.0 mmol/L in 4 weeks prior to randomization
- Currently treated with and cannot withdraw spironolactone or eplerenone due to medical necessity
- Known allergy or sensitivity to eplerenone
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 |
|---|---|---|
| eplerenonetarget 50 mg per day titrated down for hyperkalemia or hypotension | Drug | Eplerenone |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension
Time frame: 13 weeks
6 secondary outcomes
permanent discontinuation of study drug for any reason
Time frame: 13 weeks
treatment adherence
Time frame: 13 weeks
pre-dialysis potassium
Time frame: 13 weeks
frequency of serious adverse events
Time frame: 13 weeks
frequency of hospitalizations for a vascular reason
Time frame: 13 weeks
fatal and non-fatal vascular events
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Derived from this study: PubMed 33586138Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
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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.
Michael Walsh principal investigator
McMaster University, Population Health Research Institute, St. Joseph's Hospital
Ron Wald principal investigator
Keenan Research Centre, St. Michael's Hospital, University of Toronto
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eplerenone in people with Hemodialysis and End Stage Renal Disease, run by McMaster University at 5 sites in Canada.
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 4 inclusion and 7 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 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension (time frame: 13 weeks). 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 NCT01650012, 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 28 Sep 2015.