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Eplerenone in Hemodialysis Trial (PHASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01650012
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : September 28, 2015
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Eplerenone

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

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 ]

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01650012

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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)
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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
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Responsible Party: McMaster University Identifier: NCT01650012    
Other Study ID Numbers: PHASE-1
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents