RT Journal Article
T1 Slowing Progression of Cardiovascular Calcification With SNF472 in Patients on Hemodialysis: Results of a Randomized Phase 2b Study.
A1 Raggi, Paolo
A1 Bellasi, Antonio
A1 Bushinsky, David
A1 Bover, Jordi
A1 Rodriguez, Mariano
A1 Ketteler, Markus
A1 Sinha, Smeeta
A1 Salcedo, Carolina
A1 Gillotti, Kristen
A1 Padgett, Claire
A1 Garg, Rekha
A1 Gold, Alex
A1 Perelló, Joan
A1 Chertow, Glenn M
K1 Calcium
K1 Randomized controlled trials as topic
K1 Renal insufficiency, chronic
K1 Vascular calcification
AB The high cardiovascular morbidity and mortality in patients with end-stage kidney disease could be partially caused by extensive cardiovascular calcification. SNF472, intravenous myo-inositol hexaphosphate, selectively inhibits the formation and growth of hydroxyapatite. This double-blind, placebo-controlled phase 2b trial compared progression of coronary artery calcium volume score and other measurements of cardiovascular calcification by computed tomography scan during 52 weeks of treatment with SNF472 or placebo, in addition to standard therapy, in adult patients with end-stage kidney disease receiving hemodialysis. Patients were randomized 1:1:1 to SNF472 300 mg (n=92), SNF472 600 mg (n=91), or placebo (n=91) by infusion in the hemodialysis lines thrice weekly during hemodialysis sessions. The primary end point was change in log coronary artery calcium volume score from baseline to week 52. The primary efficacy analysis combined the SNF472 treatment groups and included all patients who received at least 1 dose of SNF472 or placebo and had an evaluable computed tomography scan after randomization. The mean change in coronary artery calcium volume score was 11% (95% CI, 7-15) for the combined SNF472 dose group and 20% (95% CI, 14-26) for the placebo group (P=0.016). SNF472 compared with placebo attenuated progression of calcium volume score in the aortic valve (14% [95% CI, 5-24] versus 98% [95% CI, 77-123]; P Compared with placebo, SNF472 significantly attenuated the progression of coronary artery calcium and aortic valve calcification in patients with end-stage kidney disease receiving hemodialysis in addition to standard care. Future studies are needed to determine the effects of SNF472 on cardiovascular events. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02966028.
PB Lippincott Williams & Wilkins
YR 2019
FD 2019-11-08
LK http://hdl.handle.net/10668/14665
UL http://hdl.handle.net/10668/14665
LA en
NO Raggi P, Bellasi A, Bushinsky D, Bover J, Rodriguez M, Ketteler M, et al.  Slowing Progression of Cardiovascular Calcification With SNF472 in Patients on Hemodialysis: Results of a Randomized Phase 2b Study. Circulation. 2020 Mar 3;141(9):728-739
DS RISalud
RD Apr 10, 2025