Validation of New Markers of Glomerular Filtration Rate: Dota Gadolinium and Calcium EDTA (MultiGFR)
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (45 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
Terminated on 2017-02-28, after 2014-10-31 start.
Reason given by the sponsor: “safety”
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 2017-02-28. 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) (lowers risk) · Wording
Phrases that raised it: acutetransplantationpatientsdiseaseml min
Phrases that lowered it: healthyvolunteerskgbmiml -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 19.1% (raises risk) · Sponsor's track record
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Phase: 1/2 (raises risk) · Design
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Maximum age: 75 (raises risk) · Who can join
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Primary purpose: diagnostic (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 166 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past trials: 392 (lowers risk) · Sponsor's track record
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Blinding: none (raises risk) · Design
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Keywords listed: 5 (lowers risk) · Design
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports with a death: 8.5% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- crossover (typical: parallel)
- Primary purpose
- diagnostic (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 392 (typical: 32)
- Sponsor's past termination rate
- 19.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 166 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 387 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 82 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- edetate, edetic acid, gadolinium, gadoterate, pentetic acid
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
- Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2) NCT01588756 · started 2010 · scored riskier than 12% of active trials completed
- Furosemide and Creatinine Tubular Stress Test in Order to Measure Proximal Tubule Residual Function NCT05105009 · started 2020 · scored riskier than 6% of active trials completed
- Designing a Bayesian Model of the Plasma Clearance of Calcium Edetate de Sodium for the Calculation of GFR and Validity Compared to the Renal Clearance of Inulin NCT02300376 · started 2014 · scored riskier than 42% of active trials completed
- A Glomerular Filtration Rate (GFR) Measuring Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus NCT01572610 · started 2012 · scored riskier than 12% of active trials terminated
- A Study to Evaluate the Effect of Renal Impairment on JNJ-56136379 in Adult Participants NCT04474210 · started 2020 · scored riskier than 2% 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.