Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients

NCT03303144 on ClinicalTrials.gov Phase 1/2 Rockwell Medical Technologies, Inc. (industry) Started 2017-10-01 Completed

Riskier than 65% of active trials

Model scores of the 29,894 trials active now.

Model score 19% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 21% of the time (1,462 trials).

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

How it ended

Completed on 2017-12-28, after 2017-10-01 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 2017-12-28. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: patientdialysisdonortransplantkidney
Phrases that lowered it: singlescreeningpharmacokineticsinclusiveinvestigator
Design: crossover (lowers risk) · Design
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1/2 (raises risk) · Design
Number of arms: 3 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 16.0% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports marked serious: 97.5% (raises risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Blinding: none (raises risk) · Design
Maximum age: 80 (lowers risk) · Who can join
Sponsor's past trials: 12 (lowers risk) · Sponsor's track record

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

Who can join

Minimum age: 18
Maximum age: 80 (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: 12 (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: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 81 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 21 (typical: 412.5)
Drug's FAERS reports marked serious: 97.5% (typical: 85.6%)
Drug's FAERS reports with a death: 16.0% (typical: 15.9%)

Disease area and drugs

Disease areas: urogenital
Drugs matched to FDA substances: ferric pyrophosphate

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

Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients NCT02739100 · started 2016 · scored riskier than 26% of active trials completed
Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients NCT01894906 · started 2013 · scored riskier than 22% of active trials completed
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients NCT01320202 · started 2011 · scored riskier than 62% of active trials completed
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2) NCT01322347 · started 2011 · scored riskier than 62% of active trials completed
Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis NCT02909153 · started 2017 · scored riskier than 23% 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.