Efficacity and Safety of Metformin XR in CKD Stage 1 to 3
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 5% 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 (220 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-10-10, after 2017-08-30 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 2022-10-10. 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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Sponsor's past termination rate: 14.0% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: chronickidney diseaseckdavailabledata
Phrases that lowered it: metforminplasmaxragedtype diabetes -
Phase: 2 (raises risk) · Design
-
Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: 62.8% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 7.8% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 31 (lowers risk) · Sponsor's track record
-
Number of arms: 3 (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Blinding: none (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
- 3 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 80 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 57 (typical: 32)
- Sponsor's past termination rate
- 14.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 31 (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
- 194228 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 33135 (typical: 412.5)
- Drug's FAERS reports marked serious
- 62.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, urogenital, endocrine
- Drugs matched to FDA substances
- metformin
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
- May Metformin be Used in Renal Failure? NCT02710448 · started 2012 · scored riskier than 30% of active trials completed
- Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin NCT01106131 · started 2010 · scored riskier than 8% of active trials completed
- Renal Impairment Study With ASP1941 NCT01302028 · started 2010 · scored riskier than 5% of active trials completed
- Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease NCT05638880 · started 2022 · scored riskier than 20% 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
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.