Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 7% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2016-12-06, after 2013-05-09 start.
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 2016-12-06. 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: donorstableleast monthsmonths priorsubject must
Phrases that lowered it: renaland safetyefficacy andsafety ofevaluate -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 47.1% (lowers risk) · Drug's FDA history
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Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 9.5% (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 5.1% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: single group (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 113 (lowers risk) · Sponsor's track record
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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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Number of arms: 1 (raises risk) · Design
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Maximum age: 17 (raises risk) · Who can join
-
Sponsor's past trials: 377 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
-
Disease area, neurology: No (lowers risk) · Disease area
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Keywords listed: 0 (lowers risk) · Design
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Minimum age: 12 (raises risk) · Who can join
-
Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 2949 (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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- 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
- 12 (typical: 18)
- Maximum age
- 17 (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
- 377 (typical: 32)
- Sponsor's past termination rate
- 9.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 113 (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
- 7405 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2949 (typical: 412.5)
- Drug's FAERS reports marked serious
- 47.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- abatacept, belatacept
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 Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based NCT01820572 · started 2013 · scored riskier than 57% of active trials completed
- Abatacept Conversion in Kidney Transplantation NCT04955366 · started 2021 · scored riskier than 92% of active trials completed
- Belatacept Therapy for the Failing Renal Allograft NCT01921218 · started 2013 · scored riskier than 99% of active trials completed
- Belatacept Pharmacokinetic Trial in Renal Transplantation NCT00578448 · started 2008 · scored riskier than 34% of active trials completed
- Belatacept in Liver Transplant Recipients NCT00555321 · started 2008 · scored riskier than 77% 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.