Trial design and baseline characteristics of CaLIPSO: a randomized, double-blind placebo-controlled trial of SNF472 in patients receiving haemodialysis with cardiovascular calcification
Por:
Bellasi, A, Raggi, P, Bover, J, Bushinsky, DA, Chertow, GM, Ketteler, M, Rodriguez, M, Sinha, S, Salcedo, C, Garg, R, Gold, A, Perello, J
Publicada:
1 ene 2021
Resumen:
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 300mg or SNF472 600mg 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.
Filiaciones:
Bellasi, A:
ASST Papa Giovanni XXIII, Res Innovat & Brand Reputat Unit, Bergamo, Italy
Raggi, P:
Mazankowski Alberta Heart Inst, Dept Med, Edmonton, AB, Canada
Univ Alberta, Edmonton, AB, Canada
Bover, J:
Fundacio Puigvert, Dept Nephrol, Barcelona, Spain
Univ Autonoma Barcelona, IIB St Pau, REDinREN, Barcelona, Spain
Bushinsky, DA:
Univ Rochester, Med Ctr, Dept Med, Rochester, NY 14642 USA
Chertow, GM:
Stanford Univ, Dept Med, Palo Alto, CA 94304 USA
Ketteler, M:
Robert Bosch Krankenhaus, Dept Gen Internal Med & Nephrol, Stuttgart, Germany
Rodriguez, M:
Hosp Univ Reina Sofia, Nephrol Unit, REDinREN, IMIBIC, Cordoba, Spain
Sinha, S:
Salford Royal NHS Fdn Trust, Dept Renal Med, Salford, Lancs, England
Salcedo, C:
Sanifit Therapeut, Res & Dev, Palma De Mallorca, Spain
Garg, R:
Sanifit Therapeut, Res & Dev, San Diego, CA USA
Gold, A:
Sanifit Therapeut, Res & Dev, San Diego, CA USA
Perello, J:
Sanifit Therapeut, Res & Dev, Palma De Mallorca, Spain
Green Published, gold
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