NCT01650012

Eplerenone in Hemodialysis Trial

Pilot Trial of Hemodialysis Patient Aldosterone antagoniSm With Eplerenone Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodialysis
• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	eplerenone	target 50 mg per day titrated down for hyperkalemia or hypotension
DRUG	Placebo	Placebo

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-07-25
• Last updated: 2015-09-28

Locations

5 sites across 1 country: Canada