30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 1% 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 (803 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 2011-04-30, after 2008-06-30 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 2011-04-30. 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
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: kidney diseasechronic kidneyequal toor equalgreater than
Phrases that lowered it: participantsparticipantcholesteroljapaneselipoprotein -
Has a data monitoring committee: not given (lowers risk) · Design
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Sponsor's past termination rate: 7.1% (lowers risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 2.7% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past trials: 411 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Blinding: quadruple (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 236 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 80.0% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 11461 (raises 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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (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
- 411 (typical: 32)
- Sponsor's past termination rate
- 7.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 236 (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
- 11461 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2790 (typical: 412.5)
- Drug's FAERS reports marked serious
- 80.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, urogenital
- Drugs matched to FDA substances
- fenofibric acid, rosuvastatin
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 Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly NCT00585143 · started 2008 · scored riskier than 6% of active trials completed
- Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 Tablet NCT03583905 · started 2018 · scored riskier than 7% of active trials completed
- Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease NCT06350123 · started 2024 · scored riskier than 48% of active trials completed
- A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease. NCT06675175 · started 2024 · scored riskier than 72% of active trials completed
- Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Subjects With Hypertension and Chronic Kidney Disease (CKD) With Albuminuria NCT06150924 · started 2023 · scored riskier than 9% 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.