A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

NCT01382212 on ClinicalTrials.gov Phase 3 AbbVie (prior sponsor, Abbott) (industry) Started 2011-10-31 Completed

Riskier than 17% of active trials

Model scores of the 29,894 trials active now.

Model score 10% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (181 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 2015-04-30, after 2011-10-31 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 2015-04-30. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subjectkidneystagemg dldialysis
Phrases that lowered it: evaluatesafety ofweeksvalue12
Trials the sponsor started in the prior 2 years: 48 (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Drug's FAERS reports marked serious: 67.1% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 21.5% (raises risk) · Drug's FDA history
Maximum age: 16 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Minimum age: 10 (raises risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Number of arms: 1 (raises risk) · Design
Collaborators: 0 (raises risk) · Design

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: 3 (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: 10 (typical: 18)
Maximum age: 16 (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: 39 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 48 (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: 2311 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 519 (typical: 412.5)
Drug's FAERS reports marked serious: 67.1% (typical: 85.6%)
Drug's FAERS reports with a death: 21.5% (typical: 15.9%)

Disease area and drugs

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

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 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
Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD) NCT01020487 · started 2010 · scored riskier than 23% of active trials completed
Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease NCT01071070 · started 2009 · scored riskier than 33% of active trials completed
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism NCT05543928 · started 2023 · scored riskier than 48% of active trials terminated
Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD) NCT00701805 · started 2008 · scored riskier than 52% 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.