A Dose Escalation Study in de Novo Renal Transplantation
Model scores of the 29,894 trials active now.
Model score 15% 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 13% of the time (1,304 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-10-03, after 2021-05-26 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 2023-10-03. 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: donortransplantkidneyhlatolerability pharmacokinetics
Phrases that lowered it: open labelinvestigate theto investigatesafetypharmacokinetics -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: 17.3% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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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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Blinding: none (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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Primary purpose: basic science (lowers risk) · Design
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Design: sequential (lowers risk) · Design
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Maximum age: 70 (lowers risk) · Who can join
-
Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports before start: 189476 (lowers risk) · Drug's FDA history
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
- randomized
- Design
- sequential (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- 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
- 70 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 189476 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 29840 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- mycophenolate mofetil, mycophenolic acid, 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
- A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation NCT06365437 · started 2021 · scored riskier than 37% of active trials terminated
- A Study of TCD601 in de Novo Renal Transplant Recipients NCT05669001 · started 2023 · scored riskier than 66% of active trials completed
- A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE) NCT04803058 · started 2022 · scored riskier than 99% of active trials terminated
- CCFZ533X2201 - PoC Study in de Novo Renal Transplantation NCT02217410 · started 2015 · scored riskier than 88% of active trials completed
- A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PANORAMA) NCT04803006 · started 2023 · scored riskier than 98% 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.