A Study to Learn How BAY94-8862 Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body in Adult Participants With Reduced Kidney Function and in Healthy Participants With Similar Age, Weight and Gender Distribution

NCT04908436 on ClinicalTrials.gov Phase 1 Bayer (industry) Started 2010-10-27 Completed

Riskier than 4% of active trials

Model scores of the 29,894 trials active now.

Model score 4% 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 5% of the time (233 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 2012-01-27, after 2010-10-27 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 2012-01-27. 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: Yes (lowers risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: heartfailureserumchroniccreatinine
Phrases that lowered it: healthybodyexaminationkgvisit
Phase: 1 (lowers risk) · Design
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 130 (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Sponsor's past trials: 342 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Sponsor's past termination rate: 5.0% (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Number of arms: 4 (lowers risk) · Design
Maximum age: 79 (raises risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Blinding: none (lowers 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: 1 (typical: 2)
Number of arms: 4 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: basic science (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 79 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 342 (typical: 32)
Sponsor's past termination rate: 5.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 130 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 0 (typical: 1)
Drug has FAERS history: No (typical: 64% yes)
Drug's FAERS reports before start: 0 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: no FAERS history (typical: 85.6%)
Drug's FAERS reports with a death: no FAERS history (typical: 15.9%)

Disease area and drugs

Disease areas: urogenital
Drugs matched to FDA substances: finerenone

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

Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects NCT01318551 · started 2011 · scored riskier than 2% of active trials completed
Phase 2b Study of KBP-5074 in Subjects With Uncontrolled Hypertension and Advanced Chronic Kidney Disease NCT03574363 · started 2018 · scored riskier than 84% of active trials completed
A Study to Learn How Finerenone (BAY94-8862) Moves Into, Through and Out of the Body, How it Affects the Body, and How Safe it is in Adult Participants With Different Degrees of Reduced Liver Function and in Healthy Participants With Similar Age, Weight and Gender Distribution NCT04881994 · started 2014 · scored riskier than 7% of active trials completed
Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease NCT02837237 · started 2016 · scored riskier than 11% of active trials completed
A Study to Learn How the Study Treatment BAY3283142 Taken as Single Dose by Mouth Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function of Similar Age, Gender, and Weight NCT05515432 · started 2022 · scored riskier than 10% 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.