End Stage Renal Disease, Hemodialysis
Conditions
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.
Interventions
DRUGeplerenone
target 50 mg per day titrated down for hyperkalemia or hypotension
DRUGPlacebo
Placebo
Sponsors
Canadian Institutes of Health Research (CIHR)
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension | 13 weeks |
Secondary
| Measure | Time frame |
|---|---|
| treatment adherence | 13 weeks |
| pre-dialysis potassium | 13 weeks |
| permanent discontinuation of study drug for any reason | 13 weeks |
| frequency of hospitalizations for a vascular reason | 13 weeks |
| fatal and non-fatal vascular events | 13 weeks |
| frequency of serious adverse events | 13 weeks |
Countries
Canada
Outcome results
None listed