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NCT Number: NCT01650012

Eplerenone in Hemodialysis Trial

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.

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Key information

Conditions

Hemodialysis Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eplerenone

Drug

target 50 mg per day titrated down for hyperkalemia or hypotension

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Pilot Trial of Hemodialysis Patient Aldosterone antagoniSm With Eplerenone Trial

Acronym: PHASE

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 25, 2012
Registry last updated
Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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