Eplerenone in Hemodialysis Trial (PHASE)

• ClinicalTrials.gov Identifier: NCT01650012
• Recruitment Status: Completed
• First Posted: July 25, 2012
• Last Update Posted: September 28, 2015
• Sponsor: McMaster University
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Information provided by (Responsible Party): McMaster University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hemodialysis; End Stage Renal Disease	Drug: eplerenone; Drug: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pilot Trial of Hemodialysis Patient Aldosterone antagoniSm With Eplerenone Trial
• Study Start Date: March 2013
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Eplerenone; Target of 50 mg/day	Drug: eplerenone; target 50 mg per day titrated down for hyperkalemia or hypotension
Placebo Comparator: Placebo; Matching placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension [ Time Frame: 13 weeks ]

Secondary Outcome Measures :

1. permanent discontinuation of study drug for any reason [ Time Frame: 13 weeks ]
2. treatment adherence [ Time Frame: 13 weeks ]
3. pre-dialysis potassium [ Time Frame: 13 weeks ]
4. frequency of serious adverse events [ Time Frame: 13 weeks ]
5. frequency of hospitalizations for a vascular reason [ Time Frame: 13 weeks ]
6. fatal and non-fatal vascular events [ Time Frame: 13 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada, Alberta

Calgary, Alberta, Canada

Canada, Manitoba

Winnipeg, Manitoba, Canada

Canada, Ontario

St. Joseph's Healthcare

Hamilton, Ontario, Canada

London, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Sponsors and Collaborators

McMaster University

Canadian Institutes of Health Research (CIHR)

Investigators

• Principal Investigator: Michael Walsh; McMaster University, Population Health Research Institute, St. Joseph's Hospital
• Principal Investigator: Ron Wald; Keenan Research Centre, St. Michael's Hospital, University of Toronto

More Information

• Responsible Party: McMaster University
• ClinicalTrials.gov Identifier: NCT01650012
• Other Study ID Numbers: PHASE-1
• First Posted: July 25, 2012
• Last Update Posted: September 28, 2015
• Last Verified: September 2015

Additional relevant MeSH terms:

Kidney Failure, Chronic; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Eplerenone; Mineralocorticoid Receptor Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents; Antihypertensive Agents