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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02652806 | FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease | PHASE3 | COMPLETED | 305 | — | — | Dec 1, 2015 | Jun 14, 2017 | Aug 24, 2017 | 31 | China |
| NCT02652819 | FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on Dialysis | PHASE3 | COMPLETED | 154 | — | — | Dec 1, 2015 | Jun 13, 2017 | Aug 24, 2017 | 30 | China |
| NCT03303066 | Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS) | PHASE2 | COMPLETED | 43 | — | — | Jun 6, 2018 | Feb 8, 2023 | May 3, 2023 | 38 | China |
Hemoglobin response to FG-4592 is defined as an increase in mean Hb of ≥1.0 grams (g)/deciliter (dL) from baseline within any 8-week period during the study without transfusion.
| Arm | Type | Description |
|---|---|---|
| FG-4592 | EXPERIMENTAL | Intervention is investigational treatment FG-4592 |
| EPO | ACTIVE_COMPARATOR | Intervention is subject's current dose of Li Xue Bao (epoetin alfa) |
| Placebo | PLACEBO_COMPARATOR | Double blinded placebo control |
| Phase 2 Part: FG-4592 | EXPERIMENTAL | Fixed starting doses (different doses for lower body weight \& higher body weight) of FG-4592 administered orally 3 times a week (TIW) for up to 26 weeks; dose adjustments to Hb levels are allowed during the study. |
| Phase 3 Part: FG-4592 | EXPERIMENTAL | Fixed starting doses (different doses for lower body weight \& higher body weight) of FG-4592 administered orally TIW for up to 26 weeks; dose adjustments to Hb levels are allowed during the study. |
| Phase 3 Part: Placebo | PLACEBO_COMPARATOR | Placebo (matching to FG-4592) administered orally TIW for up to 26 weeks. |
| Name | Type | Description |
|---|---|---|
| FG-4592 | DRUG | - |
| Epoetin Alfa | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Ages 18 to 75 years 2. Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC), after the nature of the study has been explained and the subject has had the opportunity to ask questions; a separate ICF is needed for subjec...