Comparison · NCT03493685-sae
Sparsentan vs Irbesartan: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Sparsentan vs Irbesartan: serious adverse events. Trial comparisons, record NCT03493685-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03493685-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.37 | 0.303 | 0.441 | wilson | |
| Risk in group 2 | 0.439 | 0.369 | 0.51 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0689 | -0.167 | 0.0307 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.843 | 0.657 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 0.751 | 0.495 | 1.14 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sparsentan than on Irbesartan | 14.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Sparsentan | Participants in this arm were randomized to receive initial dose of Sparsentan as 400 milligrams (mg) over-encapsulated (blinded) with size 00 capsules orally once daily. A dose adjustment was made for participants whose body weight was ≤50 kilograms (kg) at screening; these participants received one-half of the specified dose of Sparsentan. The dose was then titrated to achieve the maximum daily target dose of 800 mg. | 68 | 184 | EG000 |
| Group 2 | Irbesartan | Participants were randomized to receive active control doses of Irbesartan 150 mg over-encapsulated (blinded) with size 00 capsules orally once daily. A dose adjustment was made for participants whose body weight was ≤50 kg at screening; these participants received one-half of the specified dose of Irbesartan. The dose was then titrated to achieve the maximum daily target dose of 300 mg. | 82 | 187 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Week 112
Source ClinicalTrials.gov
Trial
- Title
- Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)
- NCT number
- NCT03493685
- Phases
- PHASE3
- Conditions
- Focal Segmental Glomerulosclerosis
- Interventions
- sparsentan, Irbesartan
- Lead sponsor
- Travere Therapeutics, Inc.
- Results first posted
- 2024-04-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03493685?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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