Eplerenone in Hemodialysis Trial

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Trial of Hemodialysis Patient Aldosterone antagoniSm With Eplerenone Trial

Conditions
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Hemodialysis, End Stage Renal Disease

Intervention / Treatment
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* Drug: eplerenone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eplerenone<br>Target of 50 mg/day | Drug: eplerenone<br>* target 50 mg per day titrated down for hyperkalemia or hypotension<br>|
| Placebo Comparator: Placebo<br>Matching placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension |  | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| permanent discontinuation of study drug for any reason |  | 13 weeks | 
| treatment adherence |  | 13 weeks | 
| pre-dialysis potassium |  | 13 weeks | 
| frequency of serious adverse events |  | 13 weeks | 
| frequency of hospitalizations for a vascular reason |  | 13 weeks | 
| fatal and non-fatal vascular events |  | 13 weeks |