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. 2019 Oct 30;14(1):366-374.
doi: 10.1093/ckj/sfz144. eCollection 2021 Jan.

Trial design and baseline characteristics of CaLIPSO: a randomized, double-blind placebo-controlled trial of SNF472 in patients receiving haemodialysis with cardiovascular calcification

Antonio Bellasi  1 , Paolo Raggi  2 , Jordi Bover  3 , David A Bushinsky  4 , Glenn M Chertow  5 , Markus Ketteler  6 , Mariano Rodriguez  7 , Smeeta Sinha  8 , Carolina Salcedo  9 , Rekha Garg  10 , Alex Gold  10 , Joan Perelló  9
Affiliations

Trial design and baseline characteristics of CaLIPSO: a randomized, double-blind placebo-controlled trial of SNF472 in patients receiving haemodialysis with cardiovascular calcification

Antonio Bellasi et al. Clin Kidney J. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: SNF472; chronic kidney disease; coronary artery calcification; randomized clinical trial; vascular calcification.

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Figures

FIGURE 1
FIGURE 1
CaLIPSO trial flow chart. In Step 1, potential study participants who satisfied the inclusion and exclusion criteria underwent an assessment by MDCT scanner to determine the Agatston score for the coronary artery, as well as dual-energy X-ray absorptiometry for BMD of the total hip and femoral neck. Patients with confirmed calcification of the coronary artery (initially 100–2000 U; later 100–3500 U) at Step 1 entered Step 2 to complete all other screening assessments and confirm all eligibility criteria were met.
FIGURE 2
FIGURE 2
Distribution of baseline coronary artery calcium scores (Agatston and calcium volume).
See this image and copyright information in PMC

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