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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05301517 | A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies | PHASE3 | COMPLETED | 159 | — | — | Mar 16, 2022 | Apr 21, 2023 | Jun 6, 2023 | 45 | China |
Hb levels measured from Weeks 9 through 13 will be averaged in order to provide a single measure for comparison to the baseline Hb levels.
| Arm | Type | Description |
|---|---|---|
| Roxadustat | EXPERIMENTAL | Participants will receive roxadustat, administered orally 3 times per week (TIW) for 12 weeks to achieve Hb levels of 100-120 g/L. The starting dose will be based on the participant's weight group. The maximum dose for individual participants may not exceed 3.5 milligrams (mg)/kilogram (kg) or 400 mg TIW whichever is lower. |
| SEPO® | ACTIVE_COMPARATOR | Participants will receive SEPO®, injected subcutaneously TIW for 12 weeks to achieve Hb levels of 100-120 g/L. The starting dose will be 150 international units (IU)/kg subcutaneously TIW. |
| Name | Type | Description |
|---|---|---|
| SEPO® | DRUG | SEPO® will be administered per dose and schedule specified in the arm description. |
| Roxadustat | DRUG | Roxadustat will be administered per dose and schedule specified in the arm description. |
Key Inclusion Criteria: * Diagnosis of non-myeloid malignancy, by histological or cytological confirmation. * Anemia related to myelosuppressive chemotherapy, defined as Hb ≤100 g/L at screening with documented participant's Hb level decrease ≥10 g/L after the initiation of chemotherapy as judged b...