Evidence mapPaperPMID 33564440Full record

ArticleClinical kidney journal2021

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, Paolo Raggi, Jordi Bover, David A Bushinsky, Glenn M Chertow, Markus Ketteler, Mariano Rodriguez, Smeeta Sinha, Carolina Salcedo, Rekha Garg and 2 more

Open access · goldAbstract read
In one paragraph

Article in Clinical kidney journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 6 countries.

Antonio BellasiResearch, Innovation and Brand Reputation Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.ORCID 0000-0001-7830-1645
Paolo RaggiDepartment of Medicine, Mazankowski Alberta Heart Institute and University of Alberta, Edmonton, AB, Canada.
Jordi BoverDepartment of Nephrology, Fundació Puigvert and Universitat Autònoma, IIB Sant Pau, REDinREN, Barcelona, Spain.
David A BushinskyDepartment of Medicine, University of Rochester Medical Center, Rochester, NY, USA.
Glenn M ChertowDepartment of Medicine, Stanford University, Palo Alto, CA, USA.
Markus KettelerDepartment of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.
Mariano RodriguezNephrology Unit, Hospital Universitario Reina Sofia, IMIBIC, REDinREN, Córdoba, Spain.
Smeeta SinhaDepartment of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, UK.
Carolina SalcedoResearch and Development, Sanifit Therapeutics, Palma, Spain.
Rekha GargResearch and Development, Sanifit Therapeutics, San Diego, CA, USA.
Alex GoldResearch and Development, Sanifit Therapeutics, San Diego, CA, USA.
Joan PerellóResearch and Development, Sanifit Therapeutics, Palma, Spain.
Sanifit (Spain) · ESInstituto Maimónides de Investigación Biomédica de Córdoba · ESOspedale Papa Giovanni XXIII · ITPuigvert Foundation · ESRobert Bosch Hospital · DESalford Royal NHS Foundation Trust · GBStanford University · USUniversity of Alberta · CAUniversity of Rochester Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsAdult 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.

resultsOverall, 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.

conclusionsThe 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.

Indexed as

chronic kidney diseasecoronary artery calcificationrandomized clinical trialSNF472vascular calcification

Identifiers

PMID33564440
PMCPMC7857813
OpenAlexW2982679876

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.