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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01613118 | Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis | PHASE2 | COMPLETED | 109 | — | — | Mar 1, 2014 | Mar 25, 2024 | May 15, 2025 | 33 | United States, Czechia +1 |
Primary efficacy objective is to determine the change in UP/C in FSGS patients receiving RE-021 (Sparsentan) from baseline to 8 weeks over a range of dose levels compared to treatment with irbesartan as active control.
| Arm | Type | Description |
|---|---|---|
| RE-021 (Sparsentan) 200 mg - Double-Blind Period | EXPERIMENTAL | RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 200mg. Patients at \</= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration. |
| RE-021 (Sparsentan) 400 mg - Double-Blind Period | EXPERIMENTAL | RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 400mg. Patients at \</= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration. |
| RE-021 (Sparsentan) 800 mg - Double-Blind Period | EXPERIMENTAL | RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 800mg. Patients at \</= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration. |
| Irbesartan 300 mg - Double-Blind Period | ACTIVE_COMPARATOR | The control will be administered irbesartan as a single oral dose of 150mg for the first week before escalating to 300mg for the remaining 7 weeks. Patients at \</= 50kg will receive 150mg irbesartan for the 8 week duration. |
| RE-021 (Sparsentan) - Open-Label Extension Period | EXPERIMENTAL | Includes all subjects who completed the Double-Blind period and enrolled in the Open-Label Extension period of the study. All subjects who completed the Double-Blind period were evaluated for response and safety at the Week 8 visit to determine eligibility for continued treatment on their assigned doses in an Open-Label Extension period for up to 496 additional weeks. Subjects treated with irbesartan during the Double-Blind period were offered sparsentan treatment at the dose they would have received according to the Double-Blind dose cohort in which they were enrolled. |
| Name | Type | Description |
|---|---|---|
| RE-021 (Sparsentan) | DRUG | Oral, once-daily |
| Irbesartan | DRUG | Oral, once-daily |
Inclusion Criteria 1. Biopsy-proven FSGS OR documentation of a genetic mutation in a podocyte protein associated with the disease. 2. Urine protein/creatinine ratio (Up/C) at or above 1.0 g/g. 3. Estimated glomerular filtration rate (eGFR) \>30. 4. Mean seated blood pressure (BP) \>100/60 mmHg and ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL2 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | frexalimab, brivekimig, rilzabrutinib |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| Akebia Therapeutics, Inc. | AKBA | 1 | PHASE2 | Praliciguat |
| Travere Therapeutics, Inc. | TVTX | 1 | PHASE2 | Sparsentan |
| Vera Therapeutics, Inc. Class A | VERA | 1 | PHASE2 | Atacicept |