A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis

NCT01696279 on ClinicalTrials.gov Phase 2 Shire (industry) Started 2013-02-15 Completed

Riskier than 8% of active trials

Model scores of the 29,894 trials active now.

Model score 7% 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 11% of the time (493 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 2018-11-16, after 2013-02-15 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 2018-11-16. 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: stagechronic kidneykidney diseasetreatment withdialysis
Phrases that lowered it: participantthe efficacyproductagedand safety
Design: crossover (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Trials the sponsor started in the prior 2 years: 60 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Maximum age: 17 (raises risk) · Who can join
Drug's FAERS reports with a death: 9.7% (lowers risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Sponsor's past trials: 144 (lowers risk) · Sponsor's track record
Minimum age: 10 (raises risk) · Who can join
Has a data monitoring committee: No (lowers risk) · Design
Number of arms: 2 (raises risk) · Design
Blinding: none (raises risk) · Design
Drug's FAERS reports before start: 74693 (lowers risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 17686 (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: 2
Number of arms: 2
Allocation: non randomized (typical: randomized)
Design: crossover (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 10 (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: 144 (typical: 32)
Sponsor's past termination rate: 8.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 60 (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: 74693 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 17686 (typical: 412.5)
Drug's FAERS reports marked serious: 69.7% (typical: 85.6%)
Drug's FAERS reports with a death: 9.7% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, urogenital
Drugs matched to FDA substances: carbonate, lanthanum carbonate

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 Assess the Tolerability of Oxylanthanum Carbonate in Patients With Chronic Kidney Disease on Dialysis NCT06218290 · started 2023 · scored riskier than 57% of active trials completed
Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD NCT01128179 · started 2010 · scored riskier than 30% of active trials completed
Study in Chronic Kidney Disease (CKD) Not on Dialysis NCT01110629 · started 2010 · scored riskier than 14% 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 Study in Chronic Kidney Disease (Extension From Study 14817) NCT01187628 · started 2010 · scored riskier than 13% 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.