Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03762850 | A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy | PHASE3 | ACTIVE NOT_RECRUITING | 406 | — | — | Dec 11, 2018 | Jul 1, 2026 | Apr 20, 2026 | 162 | United States, Australia +16 |
| NCT05856760 | A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN | PHASE2 | COMPLETED | 48 | — | — | May 19, 2023 | Oct 25, 2024 | Nov 20, 2025 | 30 | United States, Hong Kong |
| NCT04663204 | A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy | PHASE2 | RECRUITING | 24 | — | — | Dec 10, 2020 | Dec 31, 2027 | Jun 3, 2026 | 6 | United Kingdom |
24-hour urine sample was collected for analysis of UP/C via a mixed-model repeated-measures (MMRM) analysis. Missing responses were imputed prior to analysis using multiple imputation. Change from Baseline during the double-blind period in UP/C on the log scale was the dependent variable. Log Baseline UP/C was included as a covariate along with fixed effects for randomized treatment, time (ie, nominal visit in weeks), randomized treatment-by-time interaction, and randomization strata with participants as random effect. Estimates in log scale were back transformed. Baseline was defined as the last non-missing observation on or prior to the start of the dosing. Using Rubin's approach, estimated treatment effects are combined across all imputations to obtain overall estimates.
The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples
The primary efficacy endpoint is the change from baseline in the urine protein/creatinine ratio (UP/C), based on a 24-hour urine sample, at Week 36.
| Arm | Type | Description |
|---|---|---|
| sparsentan | EXPERIMENTAL | Double-blind: Sparsentan will be administered daily as a 200-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400- mg and continue treatment to Week 110. |
| irbesartan | ACTIVE_COMPARATOR | Double-blind: Irbesartan will be administered daily as a 150-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg and continue treatment to Week 110. |
| dapagliflozin + sparsentan (Sub study) | EXPERIMENTAL | OLE Sub study: Dapagliflozin will be administered daily as a 5-mg oral tablet, in addition to 400-mg of Sparsentan, for a period of 12 weeks. |
| sparsentan (Sub Study) | EXPERIMENTAL | OLE Sub study: Sparsentan will be administered daily as a dose of 400-mg for a period of 12 weeks. |
| Name | Type | Description |
|---|---|---|
| sparsentan | DRUG | Target dose of 400 mg daily |
| irbesartan | DRUG | Target dose of 300 mg daily |
| Dapagliflozin | DRUG | Target dose of 10 mg daily |
Key Inclusion Criteria for the Double-Blind Period: * Age 18 years or older at screening * Biopsy-proven primary IgAN * Proteinuria of ≥1 g/day at screening * eGFR ≥30 mL/min/1.73 m2 at screening * Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (maximu...