A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease

NCT01264679 on ClinicalTrials.gov Phase 3 AMAG Pharmaceuticals, Inc. (industry) Started 2011-12-27 Terminated

Riskier than 18% of active trials

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 1% 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 (803 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

Terminated on 2015-04-24, after 2011-12-27 start.

Reason given by the sponsor: “enrollment”

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 2015-04-24. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Drug's FAERS reports with a death: 10.9% (lowers risk) · Drug's FDA history
Design: single group (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 72.3% (lowers risk) · Drug's FDA history
Maximum age: 17 (raises risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Drug's FAERS reports in the prior 12 months: 9380 (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
Number of arms: 1 (raises risk) · Design
Minimum age: 0.5 (lowers risk) · Who can join
Collaborators: 0 (raises risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: keytreatment ofckdchronic kidneydisease
Phrases that lowered it: efficacy andand safetysafety ofthe efficacyparticipants
Responsible party: sponsor (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: 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: 8 (typical: 1)

Who can join

Minimum age: 0.5 (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: 5 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 6 (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: 45991 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 9380 (typical: 412.5)
Drug's FAERS reports marked serious: 72.3% (typical: 85.6%)
Drug's FAERS reports with a death: 10.9% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, urogenital, hematology
Drugs matched to FDA substances: ferrosoferric, ferumoxytol, oxide

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 Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease NCT01155375 · started 2011 · scored riskier than 21% of active trials terminated
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease NCT01155388 · started 2011 · scored riskier than 25% of active trials terminated
A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia NCT01114217 · started 2010 · scored riskier than 68% of active trials completed
A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease NCT01052779 · started 2010 · scored riskier than 83% of active trials completed
Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease NCT01630889 · started 2012 · scored riskier than 62% 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.