Trial reportBMC nephrology2019
Efficacy and safety of sodium zirconium cyclosilicate in patients with baseline serum potassium level ≥ 5.5 mmol/L: pooled analysis from two phase 3 trials.
Trial report in BMC nephrology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers.
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.
Multicenter, Two-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-Controlled Study of Safety and Efficacy of Microporous, Fractionated, Protonated Zirconium Silicate in Mild to Moderate Hyperkalemia
Multicenter, Multi-phase, Multi-dose, Prospective, Double-blind, Placebo-controlled, Maintenance Study of Safety and Efficacy of ZS (Microporous, Fractionated, Protonated Zirconium Silicate) in Hyperkalemia.
Who cites it
15 citing papers in PubMed.
- A randomized study to compare oral potassium binders in the treatment of acute hyperkalemia.BMC nephrology · 2023Trial
- [Consensus recommendations on the diagnosis and treatment of hyperkalemia of the Austrian Society of Nephrology 2026].Wiener klinische Wochenschrift · 2026Review
- Advances in Hyperkalemia Management and the Emerging Role of Sodium Zirconium Cyclosilicate.Electrolyte & blood pressure : E & BP · 2026Review
- Potassium Overdose in Patient with Chronic Kidney Disease on Losartan: A Case Report.Clinical practice and cases in emergency medicine · 2026Article
- Rethinking Potassium Management in Chronic Kidney Disease-A Modern Approach.Journal of clinical medicine · 2025Review
- Advancing crush syndrome management: the potent role of Sodium zirconium cyclosilicate in early hyperkalemia intervention and survival enhancement in a rat model.Frontiers in pharmacology · 2024Article
- Best-Practice Perspectives on Improving Early Detection and Management of Chronic Kidney Disease Associated With Type 2 Diabetes in Primary Care.Clinical diabetes : a publication of the American Diabetes Association · 2024Article
- Effectiveness, safety, and treatment pattern of sodium zirconium cyclosilicate in Chinese patients with hyperkalemia: interim analysis from a multicenter, prospective, real-world study (Actualize Study).Frontiers in pharmacology · 2024Article
- Management of hyperkalemia: Expert consensus from Kuwait - a Modified Delphi Approach.International journal of nephrology and renovascular disease · 2024Article
- Impact of ACEIs and ARBs-related adverse drug reaction on patients' clinical outcomes: a cohort study in UK primary care.The British journal of general practice : the journal of the Royal College of General Practitioners · 2023Article
- Article
- Hyperkalemia management in the emergency department: An expert panel consensus.Journal of the American College of Emergency Physicians open · 2021Article
- Acute hyperkalemia in the emergency department: a summary from a Kidney Disease: Improving Global Outcomes conference.European journal of emergency medicine : official journal of the European Society for Emergency Medicine · 2020Review
- Hyperkalemia in heart failure: Foe or friend?Clinical cardiology · 2020Review
- Acute hyperkalemia in adults.Turkish journal of emergency medicineReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundReliable, timely-onset, oral treatments with an acceptable safety profile for patients with hyperkalemia are needed. We examined the efficacy and safety of sodium zirconium cyclosilicate (SZC; formerly ZS-9) treatment for ≤ 48 h in patients with baseline serum potassium level ≥ 5.5 mmol/L.
methodsData were pooled from two phase 3 studies (ZS-003 and HARMONIZE) among patients receiving SZC 10 g three times daily. Outcomes included mean and absolute change from baseline, median time to potassium level ≤ 5.5 and ≤ 5.0 mmol/L, and proportion achieving potassium level ≤ 5.5 and ≤ 5.0 mmol/L at 4, 24, and 48 h. Outcomes were stratified by baseline potassium. Safety outcomes were evaluated.
resultsAt baseline, 125 of 170 patients (73.5%) had potassium level 5.5-< 6.0, 39 (22.9%) had potassium level 6.0-6.5, and 6 (3.5%) had potassium level > 6.5 mmol/L. Regardless of baseline potassium, mean potassium decreased at 1 h post-initial dose. By 4 and 48 h, 37.5% and 85.0% of patients achieved potassium level ≤ 5.0 mmol/L, respectively. Median (95% confidence interval) times to potassium level ≤ 5.5 and ≤ 5.0 mmol/L were 2.0 (1.1-2.0) and 21.6 (4.1-22.4) h, respectively. Fifteen patients (8.8%) experienced adverse events; none were serious.
conclusionsSZC 10 g three times daily achieved serum potassium reduction and normokalemia, with a favorable safety profile.
trial registrationClinicalTrials.gov identifiers: ZS-003: NCT01737697 and HARMONIZE: NCT02088073.
Indexed as
Identifiers
What OpenQuestion holds
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.