A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis

NCT02833857 on ClinicalTrials.gov Phase 1 Amgen (industry) Started 2017-03-14 Completed

Riskier than 26% of active trials

Model scores of the 29,894 trials active now.

Model score 12% 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 5% of the time (233 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2018-10-31, after 2017-03-14 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

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 2018-10-31. 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: 10.4% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: subject haschronickidney diseasehemodialysisreceiving
Phrases that lowered it: single dosepharmacokineticsto evaluateevaluate thekg
Phase: 1 (lowers risk) · Design
Drug's FAERS reports with a death: 50% (raises risk) · Drug's FDA history
Design: single group (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 64 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Maximum age: 17 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Blinding: none (lowers risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Drug's FAERS reports before start: 4 (lowers risk) · Drug's FDA history

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: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 1

Who can join

Minimum age: 2 (typical: 18)
Maximum age: 17 (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: 453 (typical: 32)
Sponsor's past termination rate: 10.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 64 (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: 4 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 4 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 50% (typical: 15.9%)

Disease area and drugs

Disease areas: urogenital, endocrine
Drugs matched to FDA substances: etelcalcetide

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

Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism NCT01134562 · started 2010 · scored riskier than 26% of active trials completed
Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism NCT01254565 · started 2011 · scored riskier than 64% of active trials completed
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism NCT01439867 · started 2012 · scored riskier than 59% of active trials terminated
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD) NCT04064827 · started 2020 · scored riskier than 42% of active trials terminated
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis NCT01785875 · started 2013 · scored riskier than 90% 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.