A Study of MK-7145 in Participants With Renal Insufficiency (Part I) and Heart Failure With Renal Insufficiency (Part II) (MK-7145-011)

NCT01558674 on ClinicalTrials.gov Phase 1 Merck Sharp & Dohme LLC (industry) Started 2014-05-23 Terminated

Riskier than 18% of active trials

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 7% of the time (318 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 2014-12-17, after 2014-05-23 start.

Reason given by the sponsor: “efficacy”

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 2014-12-17. 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) (lowers risk) · Wording Phrases that raised it: heartiifailuresafety tolerabilitytolerability pharmacokinetics
Phrases that lowered it: pharmacokineticsmoderateparticipantsperiodevaluate the
Sponsor's past termination rate: 17.2% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Sponsor's past trials: 1024 (raises risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 18.1% (lowers risk) · Drug's FDA history
Maximum age: 75 (raises risk) · Who can join
Design: single group (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 136 (lowers risk) · Sponsor's track record
Drug's FAERS reports in the prior 12 months: 17983 (lowers risk) · Drug's FDA history
Number of arms: 7 (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports marked serious: 83.9% (lowers risk) · Drug's FDA history
Disease area, cardiovascular: Yes (raises risk) · Disease area
Keywords listed: 0 (raises 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: 7 (typical: 2)
Allocation: non randomized (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: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 75 (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: 1024 (typical: 32)
Sponsor's past termination rate: 17.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 136 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 111123 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 17983 (typical: 412.5)
Drug's FAERS reports marked serious: 83.9% (typical: 85.6%)
Drug's FAERS reports with a death: 18.1% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular, urogenital
Drugs matched to FDA substances: furosemide, torsemide

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

Spironolactone in the Treatment of Heart Failure NCT04727073 · started 2018 · scored riskier than 86% of active trials terminated
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% NCT04435626 · started 2020 · scored riskier than 56% of active trials completed
Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic Heart Failure NCT02329834 · started 2015 · scored riskier than 5% of active trials completed
A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure NCT06299826 · started 2024 · scored riskier than 84% of active trials completed
QUantum Genomics Incremental Dosing in Heart Failure - QUID-HF NCT02780180 · started 2016 · scored riskier than 85% of active trials terminated

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.