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Eplerenone in Hemodialysis Trial (PHASE)

This study has been completed.
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: September 24, 2015
Last verified: September 2015
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • permanent discontinuation of study drug for any reason [ Time Frame: 13 weeks ]
  • treatment adherence [ Time Frame: 13 weeks ]
  • pre-dialysis potassium [ Time Frame: 13 weeks ]
  • frequency of serious adverse events [ Time Frame: 13 weeks ]
  • frequency of hospitalizations for a vascular reason [ Time Frame: 13 weeks ]
  • fatal and non-fatal vascular events [ Time Frame: 13 weeks ]

Enrollment: 158
Study Start Date: March 2013
Study Completion Date: December 2013
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: September 24, 2015

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Eplerenone
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on July 21, 2017