Eplerenone in Hemodialysis Trial (PHASE)

McMaster University

Status: Completed

Conditions: Hemodialysis; End Stage Renal Disease

Treatments: Drug: eplerenone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01650012

PHASE-1

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 2 patient groups, including a placebo group

Eplerenone

Experimental group

Description:

Target of 50 mg/day

Treatment:

Drug: eplerenone

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo