Eplerenone in Hemodialysis Trial (PHASE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01650012
First received: July 23, 2012
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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 Intervention
Hemodialysis
End Stage Renal Disease
Drug: eplerenone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of Hemodialysis Patient Aldosterone antagoniSm With Eplerenone Trial

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • permanent discontinuation of study drug for any reason [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • treatment adherence [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • pre-dialysis potassium [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • frequency of serious adverse events [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • frequency of hospitalizations for a vascular reason [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • fatal and non-fatal vascular events [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 152
Study Start Date: March 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650012

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

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01650012     History of Changes
Other Study ID Numbers: PHASE-1
Study First Received: July 23, 2012
Last Updated: November 19, 2013
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Eplerenone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014