Trial reportNephrology (Carlton, Vic.)2017
Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer hydrochloride in Japanese haemodialysis patients with hyperphosphataemia: A randomized, open-label, multicentre, 12-week phase III study.
Trial report in Nephrology (Carlton, Vic.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 5 of them syntheses that pooled 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.
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.
Who cites it
30 citing papers in PubMed, 5 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD).The Cochrane database of systematic reviews · 2025Pooled it
- Efficacy and safety of sucroferric oxyhydroxide versus sevelamer carbonate: A systematic review and meta-analysis.Hemodialysis international. International Symposium on Home Hemodialysis · 2025Pooled it
- Using iron-based phosphate binders in phosphate reduction and anemia improvement in patients receiving dialysis: a meta-analysis of randomized controlled trials.International urology and nephrology · 2021Pooled it
- Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD).The Cochrane database of systematic reviews · 2018Pooled it
- A systematic review on the efficacy and safety of PA21 versus sevelamer in dialysis patients.International urology and nephrology · 2018Pooled it
- Trial
- Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer hydrochloride in Japanese haemodialysis patients with hyperphosphataemia: A randomized, open-label, multicentre, 12-week phase III study.Nephrology (Carlton, Vic.) · 2017Trial
- Article
- Estimating the impact of pill burden on health utilities in hemodialysis therapy.Scientific reports · 2025Article
- Efficacy and Safety of Phosphate-Lowering Agents for Adult Patients with CKD Requiring Dialysis: A Network Meta-Analysis.Clinical journal of the American Society of Nephrology : CJASN · 2025Article
- Systematic Review of the Effects of Iron on Cardiovascular, Kidney, and Safety Outcomes in Patients With CKD.Kidney international reports · 2025Article
- A network meta-analysis of therapies for hyperphosphatemia in CKD based on randomized trials.Scientific reports · 2025Article
- Association of Sevelamer Initiation with Gastrointestinal Bleeding Hospitalization in Individuals Requiring Hemodialysis.American journal of nephrology · 2024Article
- Iron-based phosphorus chelator: Risk of iron deposition and action on bone metabolism in uremic rats.Experimental biology and medicine (Maywood, N.J.) · 2022Article
- Gut Microbiome-Derived Uremic Toxin Levels in Hemodialysis Patients on Different Phosphate Binder Therapies.Blood purification · 2022Article
- Crosstalk of fibroblast growth factor 23 and anemia-related factors during the development and progression of CKD (Review).Experimental and therapeutic medicine · 2021Review
- Real-world management of hyperphosphataemia with sucroferric oxyhydroxide: the VELREAL multicentre study.Clinical kidney journal · 2021Article
- Serum Phosphorus and Albumin in Patients Undergoing Peritoneal Dialysis: Interaction and Association With Mortality.Frontiers in medicine · 2021Article
- Impact of Adverse Drug Reactions in Patients with End Stage Renal Disease in Greece.International journal of environmental research and public health · 2020Article
- Phosphate binders in chronic kidney disease: an updated narrative review of recent data.Journal of nephrology · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimWe aimed to investigate the non-inferiority of PA21 (sucroferric oxyhydroxide) to sevelamer hydrochloride (sevelamer) in terms of efficacy and safety in Japanese haemodialysis patients with hyperphosphataemia.
methodsIn this Phase III, open-label, multicentre study, 213 haemodialysis patients with hyperphosphataemia were randomized to PA21 or sevelamer treatment for 12 weeks. The primary outcome was adjusted serum phosphorus concentration at the end of treatment; the non-inferiority of PA21 was confirmed if the upper limit of the two-sided 95% confidence interval (CI) is ≤0.32 mmol/L. Secondary outcomes were corrected serum calcium and intact-parathyroid hormone concentrations. Adverse events (AEs) and adverse drug reactions (ADRs) were evaluated.
resultsThe adjusted mean serum phosphorus concentration at the end of treatment confirmed the non-inferiority of PA21 for lowering serum phosphorus compared with sevelamer (1.62 vs 1.72 mmol/L; difference, -0.11 mmol/L; 95% CI, -0.20 to -0.02 mmol/L). The mean daily tablet intake was 5.6 ± 2.6 and 18.7 ± 7.1 tablets in the PA21 and sevelamer groups, respectively. The incidences of AEs and ADRs were not significantly different between the two groups.
conclusionThe non-inferiority of PA21 to sevelamer was confirmed for the treatment of Japanese haemodialysis patients with hyperphosphataemia. PA21 was effective, safe, and well tolerated, while having a considerably lower pill burden than sevelamer.
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Registered trials
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 OpenQuestion graph.