Dataset Information

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

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.

SUBMITTER: Bellasi A

PROVIDER: S-EPMC7857813 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

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 A Raggi Paolo P Bover Jordi J Bushinsky David A DA Chertow Glenn M GM Ketteler Markus M Rodriguez Mariano M Sinha Smeeta S Salcedo Carolina C Garg Rekha R Gold Alex A Perelló Joan J

Clinical kidney journal 20191030 1

<h4>Background</h4>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.<h4>Methods</h4>Adult patients on maintenance haemodialysis (≥6 months) with an Agatston coronary artery calcium score, as m ...[more]

PMID: 33564440

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Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

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