A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.
Model scores of the 29,894 trials active now.
Model score 24% 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 9% of the time (803 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-11-07, after 2017-12-14 start.
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 2018-11-07. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: randomizationhemodialysisscreeningdialysispurpose of
Phrases that lowered it: weeks precedingpatientsfemalethe weeksevaluate the -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past trials: 1476 (raises risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Maximum age: 130 (lowers risk) · Who can join
-
Blinding: triple (raises risk) · Design
-
Phase: 3 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Sponsor's past termination rate: 7.9% (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 113 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Collaborators: 0 (raises risk) · Design
-
Disease area, metabolic: Yes (lowers risk) · Disease area
-
Disease area, cancer: 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
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 1476 (typical: 32)
- Sponsor's past termination rate
- 7.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 113 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- 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
- Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia NCT03172702 · started 2017 · scored riskier than 27% of active trials completed
- ZS Ph2/3 Dose-response Study in Japan NCT03127644 · started 2017 · scored riskier than 54% of active trials completed
- Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes) NCT04847232 · started 2021 · scored riskier than 27% of active trials terminated
- A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia. NCT03528681 · started 2021 · scored riskier than 23% 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.