Pharmacokinetics of Sugammadex (MK-8616) in Participants With Moderate and Severe Renal Insufficiency (MK-8616-105)
Model scores of the 29,894 trials active now.
Model score 4% 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 5% of the time (233 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 2014-06-06, after 2013-12-11 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 2014-06-06. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: functionivstablestatuscreatinine
Phrases that lowered it: participantshealthyparticipantpharmacokineticsdays -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 17.1% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Sponsor's past trials: 1000 (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 142 (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports with a death: 4.6% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: none (lowers risk) · Design
-
Number of arms: 6 (lowers risk) · Design
-
Drug's FAERS reports marked serious: 98.5% (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
- 6 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- 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
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1000 (typical: 32)
- Sponsor's past termination rate
- 17.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 142 (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
- 131 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 66 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- sugammadex
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
- Pharmacokinetics of MK-3682B in Participants With Moderate to Severe Renal Insufficiency (MK-3682B-030) NCT02661126 · started 2016 · scored riskier than 3% of active trials completed
- A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335 NCT02894905 · started 2016 · scored riskier than 5% of active trials completed
- Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026) NCT04303156 · started 2020 · scored riskier than 5% of active trials completed
- A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment NCT06661733 · started 2024 · scored riskier than 6% of active trials completed
- Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234 NCT06845813 · started 2025 · scored riskier than 5% 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.