Abstract: PO2381
Trial Design of FRONTIER: Ferric Citrate for the Prevention of Renal Failure in Adults with Advanced CKD
Session Information
- CKD: Insights from Recent Clinical Trials and Large Real-World Effectiveness Studies
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Block, Geoffrey A., US Renal Care, Inc, Plano, Texas, United States
- Block, Martha, US Renal Care, Inc, Plano, Texas, United States
- Brillhart, Stephanie, US Renal Care, Inc, Plano, Texas, United States
- Dittrich, Mary O., US Renal Care, Inc, Plano, Texas, United States
- Chertow, Glenn Matthew, Stanford University School of Medicine, Stanford, California, United States
- Tangri, Navdeep, University of Manitoba, Winnipeg, Manitoba, Canada
Background
There are no approved therapies to delay progression to RRT or improve survival specifically in patients with advanced CKD regardless of etiology. A pilot, open-label randomized trial in 200 patients with estimated GFR < 20 ml/min/1.73m2 demonstrated statistically significant reduction in the risk of the composite endpoint of death, dialysis or transplantation in patients randomized to fixed dose ferric citrate coordination complex (FCCC) as compared to standard of care (SOC). The current trial is designed to overcome the limitations of this open-label RCT by using a pragmatic, placebo-controlled, randomized trial design.
Methods
FRONTIER will enroll 1000 patients with estimated GFR < 20 ml/min/1.73m2 who will be randomized 1:1 to either fixed dose FCCC (2 tablets/meal) or matching placebo. Enrollment will not be based on serum concentrations reflecting iron sufficiency or phosphate. Subjects will be followed for 18 months using a pragmatic schedule based solely on SOC visits. No additional trial specific visits or laboratory tests will be required. The primary objective is to determine the effect of FCCC on the time to a composite endpoint of initiation of maintenance dialysis or all-cause mortality compared to placebo. The secondary objective is to evaluate the impact of FCCC on all-cause hospitalization and the individual components of the primary endpoint.
Results
FRONTIER is a collaboration between Industry (Akebia Therapeutics is providing study medication and funding), community nephrologists (planned for 42 sites in the US) and academia. An executive steering committee has designed the clinical trial protocol and US Renal Care, Inc will be acting as the Sponsor-Investigator.
Conclusion
Based on supportive pilot data, FRONTIER will utilize a novel trial design incorporating a pragmatic approach while maintaining a randomized, placebo-control arm and generating real-world evidence to determine the effects of FCCC on clinically meaningful patient outcomes (time to dialysis or all-cause mortality).
Funding
- Commercial Support – Akebia Therapeutics