A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

NCT00642967 on ClinicalTrials.gov Phase 3 Hoffmann-La Roche (industry) Started 2008-06-30 Completed

Riskier than 19% 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 10% of the time (139 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 2010-08-31, after 2008-06-30 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 2010-08-31. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 11.3% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: chronicdialysisrenalkidney diseasestable
Phrases that lowered it: participantsefficacy andand safetysafety ofthe efficacy
Phase: 3 (lowers risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 180 (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Drug's FAERS reports with a death: 14.7% (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
Sponsor's past trials: 151 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 73.9% (lowers risk) · Drug's FDA history
Number of arms: 1 (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: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 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: 151 (typical: 32)
Sponsor's past termination rate: 11.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 180 (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: 7413 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2052 (typical: 412.5)
Drug's FAERS reports marked serious: 73.9% (typical: 85.6%)
Drug's FAERS reports with a death: 14.7% (typical: 15.9%)

Disease area and drugs

Disease areas: hematology
Drugs matched to FDA substances: epoetin, erythropoietin, polyethylene glycol

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 Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA. NCT00661388 · started 2008 · scored riskier than 16% of active trials completed
A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia NCT00773968 · started 2008 · scored riskier than 21% of active trials completed
A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis NCT00660023 · started 2008 · scored riskier than 27% of active trials completed
A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis. NCT00717821 · started 2008 · scored riskier than 18% of active trials completed
A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia NCT00699348 · started 2008 · scored riskier than 30% 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.