Eplerenone in Hemodialysis Trial

NCT01650012 | Completed

• 1 other identifier: PHASE-1
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 5

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.

Conditions

Hemodialysis; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension

  13 weeks

Secondary Outcomes (6)

• permanent discontinuation of study drug for any reason

  13 weeks

• treatment adherence

  13 weeks

• pre-dialysis potassium

  13 weeks

• frequency of serious adverse events

  13 weeks

• frequency of hospitalizations for a vascular reason

  13 weeks

Study Arms (2)

Eplerenone

EXPERIMENTAL

Target of 50 mg/day

Drug: eplerenone

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

eplerenone DRUG

target 50 mg per day titrated down for hyperkalemia or hypotension

Eplerenone

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (5)

Unknown Facility

Calgary, Alberta, Canada

Location

Unknown Facility

Winnipeg, Manitoba, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Related Publications (1)

• Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.

  PMID: 33586138 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 25, 2012
• Study Start: March 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

CA (5)