Clinical trial NCT01650012: Eplerenone in Hemodialysis Trial
Official title: Pilot Trial of Hemodialysis Patient Aldosterone antagoniSm With Eplerenone Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
End Stage Renal Disease
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-07-25
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension
timeFrame: 13 weeks
Secondary outcomes:
measure: permanent discontinuation of study drug for any reason
timeFrame: 13 weeks
measure: treatment adherence
timeFrame: 13 weeks
measure: pre-dialysis potassium
timeFrame: 13 weeks
measure: frequency of serious adverse events
timeFrame: 13 weeks
measure: frequency of hospitalizations for a vascular reason
timeFrame: 13 weeks
measure: fatal and non-fatal vascular events
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
state: Alberta
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: McMaster University, Population Health Research Institute, St. Joseph's Hospital
name: Michael Walsh
role: PRINCIPAL_INVESTIGATOR
affiliation: Keenan Research Centre, St. Michael's Hospital, University of Toronto
name: Ron Wald
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.