Efficacy and Local Tolerability of Topically Applied Heparin on the Suitability of Newly Constructed Primary Arteriovenous Fistulas in Patients Planned for Haemodialysis

NCT01382888 on ClinicalTrials.gov Phase 2 Cyathus Exquirere Pharmaforschungsgmbh (industry) Started 2011-07-31 Terminated

Riskier than 54% of active trials

Model scores of the 29,894 trials active now.

Model score 17% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (389 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 2014-04-30, after 2011-07-31 start.

Reason given by the sponsor: “enrollment”

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 2014-04-30. 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: kidneydonorplacebotransplantpatient
Phrases that lowered it: the effectevaluate theeffect ofto evaluateefficacy and
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 26.1% (raises risk) · Drug's FDA history
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Primary purpose: prevention (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Number of arms: 2 (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Drug's FAERS reports before start: 16068 (raises risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Collaborators: 0 (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Disease area, urogenital: Yes (raises risk) · Disease area
Sponsor's past trials: 0 (raises 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: 2
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: quadruple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 4 (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: 0 (typical: 32)
Sponsor's past termination rate: no earlier finished trials (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 0 (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: 16068 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3605 (typical: 412.5)
Drug's FAERS reports marked serious: 80.1% (typical: 85.6%)
Drug's FAERS reports with a death: 26.1% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular, urogenital
Drugs matched to FDA substances: heparin

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

Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access NCT02475837 · started 2015 · scored riskier than 34% of active trials completed
A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2) NCT02414841 · started 2015 · scored riskier than 60% of active trials completed
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis NCT03183245 · started 2017 · scored riskier than 84% of active trials completed
A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease NCT01305824 · started 2011 · scored riskier than 63% of active trials completed
Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis NCT02335099 · started 2014 · scored riskier than 42% 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.