Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (192 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-06-01, after 2021-04-28 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 2023-06-01. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: kidneyhearttransplantationventricularckd
Phrases that lowered it: participantsparticipantwith typediabetesmellitus -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past trials: 1662 (raises risk) · Sponsor's track record
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Maximum age: 130 (lowers risk) · Who can join
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Phase: 2 (raises risk) · Design
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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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Trials the sponsor started in the prior 2 years: 170 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 5.7% (lowers risk) · Drug's FDA history
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Blinding: triple (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 95.2% (raises risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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
- 2
- Number of arms
- 3 (typical: 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
- 7 (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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 7921 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1215 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- dapagliflozin, zibotentan
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
- A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK NCT06269484 · started 2024 · scored riskier than 92% of active trials completed
- A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease NCT04492722 · started 2020 · scored riskier than 19% of active trials terminated
- Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease NCT04595370 · started 2021 · scored riskier than 58% of active trials completed
- A Study to Investigate the Mechanistic Effects of Dapagliflozin Alone or in Combination With Balcinrenone, Compared to Balcinrenone and Placebo on Body Fluid and Electrolyte Handling and Energy Metabolism in Participants Over 50 Years of Age With Chronic Kidney Disease. NCT05884866 · started 2023 · scored riskier than 48% of active trials completed
- Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure NCT03292653 · started 2017 · scored riskier than 52% of active trials terminated
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.