A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration

NCT02331680 on ClinicalTrials.gov Phase 2 Otsuka Pharmaceutical Co., Ltd. (industry) Started 2014-12-31 Completed

Riskier than 7% of active trials

Model scores of the 29,894 trials active now.

Model score 7% 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 17% of the time (192 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 2016-05-31, after 2014-12-31 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 2016-05-31. 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) (lowers risk) · Wording Phrases that raised it: priorthe trialpatientsthe referencejudged by
Phrases that lowered it: chronic hepatitisand safetywith chronicefficacy andcoronary
Sponsor's past termination rate: 3.3% (lowers risk) · Sponsor's track record
Minimum age: 20 (lowers risk) · Who can join
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Drug's FAERS reports with a death: 32.7% (raises risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports marked serious: 95.4% (raises risk) · Drug's FDA history
Number of arms: 3 (lowers risk) · Design
Maximum age: 80 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Responsible party: sponsor (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: 2
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 2 (typical: 1)

Who can join

Minimum age: 20 (typical: 18)
Maximum age: 80 (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: 61 (typical: 32)
Sponsor's past termination rate: 3.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 15 (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: 1295 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 385 (typical: 412.5)
Drug's FAERS reports marked serious: 95.4% (typical: 85.6%)
Drug's FAERS reports with a death: 32.7% (typical: 15.9%)

Disease area and drugs

Disease areas: urogenital
Drugs matched to FDA substances: tolvaptan

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 Phase 2, Multi-center, Open-label, Dose-finding Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of OPC-41061 in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration NCT01876381 · started 2013 · scored riskier than 8% of active trials completed
Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis NCT01895322 · started 2013 · scored riskier than 14% of active trials completed
Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure NCT03772041 · started 2019 · scored riskier than 6% of active trials completed
Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease NCT02251275 · started 2014 · scored riskier than 39% of active trials completed
Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction NCT01444872 · started 2011 · scored riskier than 21% 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.