Eplerenone in Hemodialysis Trial

NCT ID: NCT01650012

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Eplerenone

Target of 50 mg/day

Group Type: EXPERIMENTAL

eplerenone

Intervention Type: DRUG

target 50 mg per day titrated down for hyperkalemia or hypotension

Placebo

Matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

eplerenone

target 50 mg per day titrated down for hyperkalemia or hypotension

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Walsh

Role: PRINCIPAL_INVESTIGATOR

McMaster University, Population Health Research Institute, St. Joseph's Hospital

Ron Wald

Role: PRINCIPAL_INVESTIGATOR

Keenan Research Centre, St. Michael's Hospital, University of Toronto

Locations

Calgary, Alberta, Canada

Winnipeg, Manitoba, Canada

St. Joseph's Healthcare

Hamilton, Ontario, Canada

London, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33586138 (View on PubMed)

Other Identifiers

PHASE-1

Identifier Type: -

Identifier Source: org_study_id