Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (493 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-02-24, after 2018-07-09 start.
Reason given by the sponsor: “business”
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 2021-02-24. 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
-
Sponsor's past termination rate: 13.8% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectkidneyreceivingmg dl000
Phrases that lowered it: visitvitaminthe studypharmacokineticsevaluate the -
Has a data monitoring committee: Yes (raises risk) · Design
-
Blinding: single (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 8.7% (lowers risk) · Drug's FDA history
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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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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 98.1% (raises risk) · Drug's FDA history
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Sponsor's past trials: 29 (lowers risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 29 (typical: 32)
- Sponsor's past termination rate
- 13.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (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
- 587 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 196 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, urogenital
- Drugs matched to FDA substances
- calcifediol
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
- Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism NCT05543928 · started 2023 · scored riskier than 48% of active trials terminated
- Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery NCT01138475 · started 2010 · scored riskier than 8% of active trials completed
- Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) NCT03299244 · started 2018 · scored riskier than 37% of active trials completed
- Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002 NCT02282813 · started 2013 · scored riskier than 68% of active trials completed
- Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH) NCT02526160 · started 2015 · scored riskier than 42% 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.