Trial design and baseline characteristics of CaLIPSO : a randomized, double-blind placebo-controlled trial of SNF472 in patients receiving haemodialysis with cardiovascular calcification
Bellasi, Antonio (Research, Innovation and Brand Reputation Unit, ASST Papa Giovanni XXIII)
Raggi, Paolo (Department of Medicine, Mazankowski Alberta Heart Institute and University of Alberta)
Bover, Jordi (Institut d'Investigació Biomèdica Sant Pau)
Bushinsky, David A. (Department of Medicine, University of Rochester Medical Center)
Chertow, Glenn M. (Department of Medicine, Stanford University)
Ketteler, Markus (Department of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus)
Rodriguez, Mariano (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Sinha, Smeeta (Department of Renal Medicine, Salford Royal NHS Foundation Trust)
Salcedo, Carolina (Research and Development, Sanifit Therapeutics)
Garg, Rekha (Research and Development, Sanifit Therapeutics)
Gold, Alex (Research and Development, Sanifit Therapeutics)
Perelló, Joan (Research and Development, Sanifit Therapeutics)
Universitat Autònoma de Barcelona

Date:	2019
Abstract:	The objective of CaLIPSO, a Phase 2b, randomized, double-blind, placebo-controlled clinical trial, is to test the hypothesis that myo-inositol hexaphosphate (SNF472) attenuates the progression of cardiovascular calcification in patients receiving maintenance haemodialysis. Here we report the trial design and baseline characteristics of trial participants. Adult patients on maintenance haemodialysis (≥6 months) with an Agatston coronary artery calcium score, as measured by a multidetector computed tomography scanner, of 100-3500 U were enrolled. Patients were stratified by Agatston score (100-<400, 400-1000 or >1000 U) and randomized in a 1:1:1 ratio to receive placebo, SNF472 300 mg or SNF472 600 mg administered intravenously three times weekly during each haemodialysis session. Overall, 274 patients were randomized. The mean age of trial participants was 63. 6 (standard deviation 8. 9) years and 39% were women. The coronary artery, aorta and aortic valve median (25th-75th percentile) Agatston scores at baseline were 730 U (315-1435), 1728 U (625-4978) and 103 U (31-262), respectively, and the median (25th-75th percentile) calcium volume scores at baseline were 666 (310-1234), 1418 (536-4052) and 107 (38-278), respectively. Older age and diabetes mellitus were associated with higher calcium scores at baseline. The CaLIPSO trial enrolled patients on haemodialysis with pre-existent cardiovascular calcification to test the hypothesis that SNF472 attenuates its progression in the coronary arteries, aorta and aortic valve.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Chronic kidney disease ; Coronary artery calcification ; Randomized clinical trial ; SNF472 ; Vascular calcification
Published in:	Clinical Kidney Journal, Vol. 14 (october 2019) , p. 366-374, ISSN 2048-8513

DOI: 10.1093/ckj/sfz144
PMID: 33564440

9 p, 506.6 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
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