Tetrahydrobiopterin in Patients With Chronic Kidney Disease (CKD) and Albuminuria
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 13% 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 (130 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 2008-09-30, after 2008-05-31 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 2008-09-30. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patientsprogressionstageegfruncontrolled
Phrases that lowered it: screeningsubjectdisordersalcoholsafety -
Sponsor's past termination rate: 2.2% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 44 (lowers risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Responsible party: principal investigator (lowers risk) · Design
-
Drug's FAERS reports marked serious: 68.7% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports with a death: 8.2% (lowers risk) · Drug's FDA history
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor's past trials: 45 (lowers risk) · Sponsor's track record
-
Number of arms: 1 (raises risk) · Design
-
Blinding: none (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
- 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
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 45 (typical: 32)
- Sponsor's past termination rate
- 2.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 44 (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
- 25166 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4955 (typical: 412.5)
- Drug's FAERS reports marked serious
- 68.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- ascorbic acid, sapropterin
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 in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses NCT05491642 · started 2022 · scored riskier than 43% of active trials completed
- Randomized Study of Extended Treatment With Firibastat in Treatment-Resistant Hypertension (REFRESH) NCT04857840 · started 2021 · scored riskier than 66% of active trials terminated
- Exercise Intolerance in Renal Failure NCT01356966 · started 2011 · scored riskier than 28% of active trials completed
- A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease NCT06522997 · started 2024 · scored riskier than 49% of active trials completed
- Study on the Safety of the Drug Runcaciguat and How Well it Works When Given at the Highest Dose as Tolerated by Individual Patient Whose Kidneys Are Not Working Properly and Suffering at the Same Time From High Blood Sugar and/or High Blood Pressure and a Disease of the Heart and the Blood Vessels. NCT04507061 · started 2020 · scored riskier than 49% 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.