A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With Anemia

NCT02988973 on ClinicalTrials.gov Phase 3 Astellas Pharma Inc (industry) Started 2017-01-12 Completed

Riskier than 17% of active trials

Model scores of the 29,894 trials active now.

Model score 10% 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 9% of the time (181 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2020-03-26, after 2017-01-12 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 2020-03-26. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Minimum age: 20 (lowers risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subjectkidneydialysisscreeningsubjects
Phrases that lowered it: and safetyefficacy andpatientssafety ofaminotransferase
Phase: 3 (lowers risk) · Design
Sponsor's past termination rate: 5.2% (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 24 (lowers risk) · Sponsor's track record
Sponsor's past trials: 420 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
Drug's FAERS reports with a death: 20% (lowers risk) · Drug's FDA history
Number of arms: 3 (lowers risk) · Design
Collaborators: 1 (raises risk) · Design
Disease area, neurology: No (lowers risk) · Disease area

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: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 20 (typical: 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: 420 (typical: 32)
Sponsor's past termination rate: 5.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 24 (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: 5 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 4 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 20% (typical: 15.9%)

Disease area and drugs

Disease areas: urogenital, hematology
Drugs matched to FDA substances: roxadustat

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 of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia NCT02964936 · started 2017 · scored riskier than 20% of active trials completed
A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia NCT02952092 · started 2016 · scored riskier than 27% of active trials completed
A Study of Intermittent Oral Dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-Naive Hemodialysis Chronic Kidney Disease Patients With Anemia NCT02780141 · started 2016 · scored riskier than 16% of active trials completed
A Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoieses Stimulating Agent (ESA) Treatment NCT02779764 · started 2016 · scored riskier than 17% of active trials completed
A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia NCT02780726 · started 2016 · scored riskier than 26% 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.