Study Type
Interventional - Drug
completed
Mineralocorticoid receptor antagonism reduces morbidity and mortality in patients with heart failure, but the safety of these drugs in patients receiving dialysis is unclear. This study evaluated whether hyperkalemia and/or hypotension limited the use of eplerenone, a selective mineralocorticoid receptor antagonist, in hemodialysis patients.
The objective of the PHASE study was to determine the tolerability of eplerenone in patients with end state renal disease (ESRD) requiring dialysis.
This was a randomized controlled trial of prevalent patients receiving hemodialysis at five Canadian centres.
Primary endpoint:
Permanent discontinuation of the drug because of hyperkalemia or hypotension.
Secondary endpoints:
- Hyperkalemia
- Hypotension
- Cardiovascular events.
Study Design
Randomized, double-blind, placebo control
NO. of Countries
1
NO. of Sites
5
NO. of Participants
152
Study Period
2012 - 2014
Sponsor
PHRI
Michael Walsh
Scientist
Michael Walsh
Scientist
Michael Walsh is a Principal Investigator in the Renal research program at PHRI, and an Assistant Professor, Department of Medicine (nephrology), McMaster University. His research activities are in the areas of the treatment of patients who require dialysis, severe glomerular disease, and perioperative acute kidney injury. He has published more than 70 papers and two book chapters.
He holds a Kidney Research Scientist Core Education and National Training (KRESCENT) Program New Investigator award through CIHR and the Kidney Foundation of Canada. He’s received multiple Top Abstract awards from the Canadian Society of Nephrology, the Chalmers Prize from the Society for Clinical Trials, and the Detweiller Traveling Scholar Award from the College of Physicians and Surgeons of Canada.
Jackie Bosch
Scientist
Jackie Bosch
Scientist
Jackie Bosch started working with Salim Yusuf in 1993, before PHRI was formally created, as she was completing her Masters in Clinical Epidemiology, with the intent to learn how to do clinical trials so she could run trials in post-stroke rehabilitation. Most recently, she has been a co-investigator on large trials in primary and secondary prevention of cardiovascular disease and diabetes, as well as understanding the causes of functional decline as well as developing simple, internationally applicable interventions to improve post-stroke disability.
She is Assistant Dean of the Occupational Therapy program, School of Rehabilitation Sciences, McMaster University, and has received awards such as the (McMaster) President’s Award for Outstanding Service, and the PHRI Award for Outstanding Contributions to Global Collaborations. She has more than 65 peer-reviewed publications.
Jessica Tyrwhitt
Program Manager
Jessica Tyrwhitt
Program Manager
Jessica Tyrwhitt has more than 10 years’ experience in coordinating and managing large, international clinical trials. She oversees interventional trials, registries, and observational research studies looking at primary and secondary prevention of cardiovascular disease in a variety of therapeutic areas, including cardiology, thrombosis, nephrology, cardio-oncology and diabetes.
She holds an Honours Bachelor of Science Degree & Business from the University of Waterloo.
