Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.

NCT00752791 on ClinicalTrials.gov Phase 2 Takeda (industry) Started 2008-10-31 Completed

Riskier than 80% of active trials

Model scores of the 29,894 trials active now.

Model score 22% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 25% of the time (96 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 2010-05-31, after 2008-10-31 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 2010-05-31. 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: the patientcellenrollmenttherapytransplant
Phrases that lowered it: participantsmonths beforesafetydisorderthe screening
Sponsor's past termination rate: 15.9% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Design: single group (raises risk) · Design
Trials the sponsor started in the prior 2 years: 68 (lowers risk) · Sponsor's track record
Maximum age: 90 (lowers risk) · Who can join
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
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
Blinding: none (raises risk) · Design
Sponsor's past trials: 126 (lowers risk) · Sponsor's track record
Number of arms: 1 (raises risk) · Design
Responsible party: sponsor (lowers 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: 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: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 90 (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: 126 (typical: 32)
Sponsor's past termination rate: 15.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 68 (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: 1 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (typical: 15.9%)

Disease area and drugs

Disease areas: hematology
Drugs matched to FDA substances: peginesatide

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

Safety and Efficacy of Peginesatide Injection for the Maintenance of Anemia in Chronic Renal Failure Participants Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa. NCT00752609 · started 2008 · scored riskier than 88% of active trials completed
Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA NCT00680043 · started 2008 · scored riskier than 86% of active trials completed
Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis NCT01478971 · started 2011 · scored riskier than 49% of active trials completed
A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects NCT03418168 · started 2018 · scored riskier than 38% of active trials completed
A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin NCT01473407 · started 2012 · scored riskier than 95% 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.