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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02174731 | Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis. | PHASE3 | COMPLETED | 2,133 | — | — | Jul 1, 2014 | Sep 26, 2018 | Dec 16, 2019 | 188 | United States, Australia +16 |
| NCT02174627 | Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis | PHASE3 | COMPLETED | 2,781 | — | — | Jun 26, 2014 | Oct 4, 2018 | Dec 16, 2019 | 359 | United States, Argentina +24 |
Baseline Hb was defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to the participants mean level from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation Analysis of Covariance (ANCOVA). Baseline Hb was used as a covariate and treatment group, cardiovascular (CV) history, geographic region and dialysis duration as fixed effects. The adjusted least squares (LS) mean estimates of change from baseline during Week 28 to Week 52 are presented.
| Arm | Type | Description |
|---|---|---|
| Roxadustat | EXPERIMENTAL | - |
| Epoetin alfa | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Roxadustat | DRUG | Roxadustat will be administered orally three times a week (TIW) to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL. |
| Epoetin alfa | DRUG | Epoetin alfa will be administered TIW consistent with approved prescribing information for epoetin alfa to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL. |
| Placebo | DRUG | The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL. |
Inclusion criteria: 1. Provision of Informed Consent prior to any study specific procedures 2. Age ≥18 years at screening visit 1 3. Previous versions of the protocol prior to US amendment ver 6.0 and outside of US amendment ver 7.0: Receiving or initiating hemodialysis or peritoneal dialysis f...