Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (493 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2024-03-07, after 2021-04-30 start.
Reason given by the sponsor: “other”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-03-07. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
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Sponsor's past trials: 1662 (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: donortransplantbirthcontrolpregnancy test
Phrases that lowered it: participantparticipantsthe effecteffect ofevaluate the -
Drug's FAERS reports marked serious: 55.0% (lowers risk) · Drug's FDA history
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Maximum age: 130 (lowers risk) · Who can join
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Sponsor's past termination rate: 8.1% (raises risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 170 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 20.2% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Disease area, neurology: No (lowers risk) · Disease area
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 130 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1662 (typical: 32)
- Sponsor's past termination rate
- 8.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 170 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 382 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 208 (typical: 412.5)
- Drug's FAERS reports marked serious
- 55.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, metabolic
- Drugs matched to FDA substances
- zirconium cyclosilicate
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects NCT04217590 · started 2020 · scored riskier than 96% of active trials completed
- A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients. NCT03303521 · started 2017 · scored riskier than 87% of active trials completed
- Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease NCT04727528 · started 2021 · scored riskier than 50% of active trials terminated
- A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia NCT05056727 · started 2021 · scored riskier than 40% of active trials terminated
- ZS Ph2/3 Dose-response Study in Japan NCT03127644 · started 2017 · scored riskier than 54% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.