Eplerenone in Hemodialysis Trial

End Stage Renal Disease Clinical Trial

— PHASE  

Official title:

Pilot Trial of Hemodialysis Patient Aldosterone antagoniSm With Eplerenone Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650012
• Other study ID #: PHASE-1
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: September 24, 2015
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: September 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis
• Kidney Failure, Chronic

Intervention

Drug:
• eplerenone
target 50 mg per day titrated down for hyperkalemia or hypotension
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension		13 weeks	Yes
Secondary	permanent discontinuation of study drug for any reason		13 weeks	Yes
Secondary	treatment adherence		13 weeks	No
Secondary	pre-dialysis potassium		13 weeks	Yes
Secondary	frequency of serious adverse events		13 weeks	Yes
Secondary	frequency of hospitalizations for a vascular reason		13 weeks	Yes
Secondary	fatal and non-fatal vascular events		13 weeks	Yes