Study Type
Interventional - Drug
completed
The objective of the 416858-CS4 study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS 416858 in End-Stage Renal Disease (ESRD) patient on hemodialysis. (ISIS-FXI-RX is an Antisense Inhibitor of Factor.)
This study demonstrated that:
- Hemodialysis had no effect on IONIS-FXIRx pharmacokinetics
- IONIS-FXIRx was well tolerated and produced sustained, and dose-dependent reductions in FXI antigen and activity
- IONIS-FXIRx reduced severe dialysis circuit clotting events beyond standard heparin use.
- These data support further evaluation of IONIS-FXIRx as a potentially safe, effective antithrombotic therapy in ESRD patients on hemodialysis
Study Design
Phase 2 double blind, placebo controlled RCT
NO. of Countries
1
NO. of Sites
8
NO. of Participants
49
Study Period
2015 - 2016
Sponsor
IONIS Pharmaceuticals
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.
Tara McCready
Program Director
Tara McCready
Program Director
Tara McCready, PhD, oversees a variety of collaborative programs at PHRI, and serves as Project Manager for PHRI research studies and registries.
She was recruited to PHRI as a Program Director for the Canadian Network and Centre for Trials Internationally (CANNeCTIN), a national network funded by the CIHR/CFI Clinical Research Initiative program to improve the prevention and treatment of cardiac and vascular diseases and diabetes.
Previously the Executive Director of the Canadian Maternal, Infant, Child and Youth Research Network, Tara holds a PhD in Biochemistry and a MBA in Technology Commercialization from the University of Alberta.
