Abstract: TH-OR18
SNF472 Consistently Slows Progression of Coronary Artery Calcification Across Subgroups of Patients on Hemodialysis
Session Information
- Novel Approaches to Mineral and Bone Metabolism
October 22, 2020 | Location: Simulive
Abstract Time: 05:00 PM - 07:00 PM
Category: Bone and Mineral Metabolism
- 402 Bone and Mineral Metabolism: Clinical
Authors
- Chertow, Glenn Matthew, Department of Medicine, Stanford University, Palo Alto, California, United States
- Raggi, Paolo, Mazankowski Alberta Heart Institute and University of Alberta, Edmonton, Alberta, Canada
- Bellasi, Antonio, Research, Innovation and Brand Reputation Unit, ASST Papa Giovanni XXIII, Bergamo, Italy
- Bushinsky, David A., Department of Medicine, University of Rochester Medical Center, Rochester, New York, United States
- Bover, Jordi, Department of Nephrology, Fundació Puigvert and Universitat Autònoma, IIB Sant Pau, REDinREN, Barcelona, Spain
- Rodriguez, Mariano, Nephrology Unit, Hospital Universitario Reina Sofia, IMIBIC, REDinREN, Cordoba, Spain
- Ketteler, Markus, Department of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus, Stuttgart, Germany
- Sinha, Smeeta, Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, United Kingdom
- Garg, Rekha, Research and Development, Sanifit (now with PharmaDRS Consulting), San Diego, California, United States
- Padgett, Claire S., Research and Development, Sanifit, San Diego, California, United States
- Perelló, Joan, Research and Development, Sanifit, Palma, Spain
- Gold, Alex, Research and Development, Sanifit, San Diego, California, United States
Background
In the CaLIPSO study, SNF472 significantly attenuated progression of coronary artery calcium (CAC) volume score compared with placebo. This pre-specified analysis examined CAC progression in key subgroups.
Methods
Patients were randomized to SNF472 300 mg (n=92), SNF472 600 mg (n=91) or placebo (n=91) infused 3x/week during hemodialysis (HD) for 52 weeks on top of standard care therapy determined by each investigator. We examined change in log CAC volume score from baseline to week 52 in the combined SNF472 dose groups vs placebo for subgroups of age, sex, diabetes, dialysis vintage, arteriosclerotic cardiovascular disease (ASCVD), use of non-Ca phosphate binders, Ca-based phosphate binders, calcimimetics, activated vitamin D, warfarin, or statins in the modified ITT population (mITT, defined as subjects who received at least one dose of study drug and had an evaluable post-baseline CT scan).
Results
Baseline characteristics were similar across treatment groups: mean age was 64 y, 39% were female; 62% had diabetes, and 41% had prior ASCVD. Median HD vintage was 42 mo; 33% received HD for ≥5 years. Concomitant medications at baseline were: 62% non-Ca phosphate binders, 28% Ca-based phosphate binders, 31% calcimimetics, 51% activated vit D, 8% warfarin, and 64% statins. In the overall mITT, CAC volume progression was 11% in the combined SNF472 groups vs 20% in placebo (p=0.016). Treatment differences for CAC volume progression were similar across subgroups (Figure). All interaction p-values were non-significant and comparisons favored SNF472 vs placebo in each subgroup.
Conclusion
SNF472 treatment for 52 weeks attenuated CAC progression compared with placebo in all subgroups.
Funding
- Commercial Support –