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Comparison · NCT03762850-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 NCT03762850-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03762850-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3710.3080.44wilson
Risk in group 20.3510.2890.42wilson
Risk difference, group 1 minus group 20.0198-0.07340.112newcombe hybrid score
Risk ratio, group 1 over group 21.060.8151.37log
Odds ratio, group 1 over group 21.090.7261.64log
Number needed to harm, for one more participant with a serious adverse event on Sparsentan than on Irbesartan50.5from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Sparsentan
Participants randomized to Sparsentan received initial dose of 200 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
75202EG000
Group 2Irbesartan
Participants randomized to Irbesartan received initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
71202EG001

Harm

What it counts
Total, serious adverse events
Time frame
Up to Week 114

Source ClinicalTrials.gov

Trial

Title
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy
NCT number
NCT03762850
Phases
PHASE3
Conditions
Immunoglobulin A Nephropathy
Interventions
sparsentan, irbesartan, Dapagliflozin
Lead sponsor
Travere Therapeutics, Inc.
Results first posted
2024-07-03

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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