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
Senior Scientist
Michael Walsh
Senior 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 is the Assistant Dean of the McMaster Occupational Therapy Program and a PHRI Scientist. She has a Bachelor’s degree in Occupational Therapy, a Master’s degree in Clinical Epidemiology and Biostatistics, and a PhD in Rehabilitation Science. She also serves as a Professor in the School of Rehabilitation and has an Adjunct Appointment with the University of Galway College of Medicine, Nursing, and Health Sciences.
Her research focuses on improving functional outcomes in clinical trials, particularly for stroke survivors in low-resource settings, and enhancing clinical trial methods. Bosch has taken on leadership roles in large-scale trials such as HOPE, HOPE-TOO, HOPE-3 (NCT00468923), DREAM (NCT00095654), ORIGIN (NCT00069784), TIPS-3 (NCT01646437), and COMPASS (NCT01776424). She leads the Organized Stroke Care Across Income Levels (OSCAIL) group, which has conducted a proof-of-concept study implementing key aspects of stroke unit care in hospitals within low-resource settings. Currently, the OSCAIL group is working on a community-based study aimed at improving outcomes for stroke survivors in these challenging environments. Bosch is also interested in optimizing how clinical trials are conducted, especially by finding new ways to make the start-up and execution processes more efficient.
Jackie Bosch has published 184 articles and received several awards, including the Lorna Reimer Award for Leadership from the Canadian Occupational Therapy Foundation in 2019 and the Faculty of Health Sciences, McMaster University, Programs Award for Graduate Students in 2014.
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.
