Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types
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 17% of the time (192 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-08-04, after 2016-05-11 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 2021-08-04. 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: Yes (lowers risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: stagecancertypewomencell
Phrases that lowered it: participanthealthysubjectparticipantsscreening -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Number of arms: 13 (lowers risk) · Design
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Drug's FAERS reports with a death: 5.3% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 86.8% (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Blinding: none (raises risk) · Design
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Primary purpose: basic science (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
- 2
- Number of arms
- 13 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- basic science (typical: 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
- 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
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 2158 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 609 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- iohexol
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 Bioequivalence and Efficacy Study of MB-102 (Relmapirazin) in Chinese Participants NCT05943977 · started 2023 · scored riskier than 2% of active trials completed
- Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis NCT05099445 · started 2021 · scored riskier than 10% of active trials completed
- A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment NCT04348175 · started 2020 · scored riskier than 3% of active trials completed
- Evaluate Safety and Pharmacokinetics of Minocin (Minocycline) for Injection in Subjects With Renal Insufficiency NCT02808052 · started 2017 · scored riskier than 4% of active trials terminated
- Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects NCT05425719 · started 2022 · scored riskier than 2% 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.