Trial reportClinical and experimental nephrology2025
Efficacy and safety of patiromer for non-dialysis and dialysis patients with hyperkalemia: the randomized, placebo-controlled and long-term study.
Trial report in Clinical and experimental nephrology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
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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
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and Tolerability of Sodium Zirconium Cyclosilicate or Patiromer in Managing Hyperkalemia: A Systematic Review and Meta-Analysis.Kidney360 · 2026Pooled it
- [Consensus recommendations on the diagnosis and treatment of hyperkalemia of the Austrian Society of Nephrology 2026].Wiener klinische Wochenschrift · 2026Review
- Prevalence, recurrence, risk factors and adverse clinical outcomes of hyperkalemia in maintenance hemodialysis patients.BMC nephrology · 2025Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe objectives of this phase two study are to investigate the efficacy of two starting doses of 8.4 g and 16.8 g and evaluate the long-term safety of patiromer in Japanese patients with hyperkalemia.
methodsThis study comprised three cohorts; non-dialysis patients with baseline serum potassium (sK) level of 5.1 to < 6.0 mmol/L (NDC1); 6.0 to < 6.5 mmol/L (NDC2); dialysis patients with baseline sK level of 5.5 to < 6.5 mmol/L (DC). The study design was one-week, randomized, double-blind, placebo-controlled, and open label extension for one year in NDC1, open label during the study in NDC2 and DC. Patients were randomly assigned to patiromer 8.4 g, 16.8 g or placebo in NDC1, 8.4 g or 16.8 g in NDC2 and DC. Dose was adjusted up to 25.2 g according to the titration algorism in open label period.
resultsA total of 185 patients were randomized (NDC1:153, NDC2:10, and DC:22). The primary endpoint of the change in least squares mean sK levels at Week 1 in NDC1 was - 0.55, - 0.77 and - 0.10 mmol/L for the 8.4 g, 16.8 g and placebo group (P < 0.001 for the patiromer group vs the placebo group). In all cohorts for each patiromer group, more than 80% of patients achieved normal sK at Week 5. There was no severe treatment-related adverse event.
conclusionTreatment with patiromer was effective in lowering and maintaining target sK levels, also well tolerated for one year in Japanese patients with hyperkalemia.
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