Efficacy and Safety of Rituximab to That of Calcineurin Inhibitors in Children With Steroid Dependent Nephrotic Syndrome
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 11% of the time (234 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-09-30, after 2015-05-08 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 2016-09-30. 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: cellscellremissionrelapsetreating
Phrases that lowered it: and safetyefficacy andsafety ofvaccinationsingle -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 25.0% (raises risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 95.2% (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 3 (lowers risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 16 (raises risk) · Who can join
-
Sponsor's past trials: 3 (raises risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports before start: 61111 (lowers risk) · Drug's FDA history
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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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 3 (typical: 18)
- Maximum age
- 16 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 61111 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 12279 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- rituximab, tacrolimus
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
- Rituximab for Idiopathic Nephrotic Syndrome NCT04494438 · started 2013 · scored riskier than 50% of active trials completed
- Efficacy and Safety of Rituximab in the First Episode of Pediatric Idiopathic Nephrotic Syndrome NCT04783675 · started 2021 · scored riskier than 54% of active trials completed
- Efficacy of Rituximab For the Treatment of Calcineurin Inhibitors Dependent Nephrotic Syndrome During Childhood NCT01268033 · started 2010 · scored riskier than 55% of active trials completed
- Compare Efficacy and Safety of Repeated Courses of Rituximab to That of Maintenance Mycophenolate Mofetil Following Single Course of Rituximab Among Children With Steroid Dependent Nephrotic Syndrome NCT03899103 · started 2019 · scored riskier than 25% of active trials completed
- Ofatumumab Versus Rituximab in Children With Steroid and Calcineurin Inhibitor Dependent Idiopathic Nephrotic Syndrome NCT02394119 · started 2015 · scored riskier than 46% 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.