Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)
Model scores of the 29,894 trials active now.
Model score 13% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2014-11-07, after 2013-10-28 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2014-11-07. 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
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjects withdiagnosisheartdefinedplacebo controlled
Phrases that lowered it: japanesetype diabeteswith typem2mellitus -
Has a data monitoring committee: Yes (raises risk) · Design
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Phase: 2 (raises risk) · Design
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Number of arms: 8 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Sponsor's past trials: 489 (raises risk) · Sponsor's track record
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Sponsor's past termination rate: 6.7% (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 80 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Blinding: triple (raises risk) · Design
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Maximum age: not given (lowers 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 before start: 0 (raises risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 0 (raises risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Collaborators: 0 (raises 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
- 8 (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
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (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
- 489 (typical: 32)
- Sponsor's past termination rate
- 6.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 80 (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
- urogenital, endocrine
- Drugs matched to FDA substances
- finerenone
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
- Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy NCT01874431 · started 2013 · scored riskier than 32% of active trials completed
- A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease NCT03412006 · started 2018 · scored riskier than 40% of active trials completed
- Study to Evaluate the Effects of BMS-813160 on Protein Loss in the Urine of Subjects With Type 2 Diabetes and Diabetic Kidney Disease NCT01752985 · started 2013 · scored riskier than 31% of active trials terminated
- Phase IIb Safety and Efficacy Study of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Moderate Chronic Kidney Disease Alone NCT01955694 · started 2013 · scored riskier than 35% of active trials completed
- A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria NCT01847092 · started 2013 · scored riskier than 20% 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.