Real-world safety and effectiveness of sucroferric oxyhydroxide for treatment of hyperphosphataemia in dialysis patients: a prospective observational study

Background The iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), is indicated to control serum phosphorus levels in patients with chronic kidney disease on dialysis. Methods This non-interventional, prospective, multicentre, cohort study conducted in seven European countries evaluat...

Full description

Saved in:
Bibliographic Details
Published in:Clinical Kidney Journal 2021-07, Vol.14 (7), p.1770-1779
Main Authors: Vervloet, Marc G, Boletis, Ioannis N, de Francisco, Angel L M, Kalra, Philip A, Ketteler, Markus, Messa, Piergiorgio, Stauss-Grabo, Manuela, Derlet, Anja, Walpen, Sebastian, Perrin, Amandine, Ficociello, Linda H, Rottembourg, Jacques, Wanner, Christoph, Cannata-Andía, Jorge B, Fouque, Denis
Format: Article
Language:English
Subjects:
Analysis
Care and treatment
Chronic kidney failure
Ferritin
Human health and pathology
Life Sciences
Medical research
Medicine, Experimental
Original
Patient compliance
Phosphates
Safety and security measures
Sevelamer carbonate
Citations: Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Background The iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), is indicated to control serum phosphorus levels in patients with chronic kidney disease on dialysis. Methods This non-interventional, prospective, multicentre, cohort study conducted in seven European countries evaluated the safety and effectiveness of SFOH in dialysis patients with hyperphosphataemia in routine practice. Safety outcomes included adverse drug reactions (ADRs) and changes in iron-related parameters. SFOH effectiveness was evaluated by changes-from-baseline (BL) in serum phosphorus and percentage of patients achieving in-target phosphorus levels. Results The safety analysis set included 1365 patients (mean observation: 420.3 ± 239.3 days). Overall, 682 (50.0%) patients discontinued the study. Mean SFOH dose during the observation period was 1172.7 ± 539.9 mg (2.3 pills/day). Overall, 617 (45.2%) patients received concomitant PB(s) during SFOH treatment. ADRs and serious ADRs were observed for 531 (38.9%) and 26 (1.9%) patients. Most frequent ADRs were diarrhoea (194 patients, 14.2%) and discoloured faeces (128 patients, 9.4%). Diarrhoea generally occurred early during SFOH treatment and was mostly mild and transient. Small increases from BL in serum ferritin were observed (ranging from +12 to +75 µg/L). SFOH treatment was associated with serum phosphorus reductions (6.3 ± 1.6 mg/dL at BL versus 5.3 ± 1.8 mg/dL at Month 30; ΔBL: −1.0 mg/dL, P 
ISSN:2048-8505
2048-8513
DOI:10.1093/ckj/sfaa211