Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Roxadustat · 2 trials · 1 indication
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...
Roxadustat is an investigational small molecule being developed for the treatment of anemia. It is being studied in patients with chronic kidney disease (CKD), both those not on dialysis and those on dialysis. The drug is currently in Phase 3 clinical development.
Roxadustat is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in treating anemia in patients with chronic kidney disease.
Roxadustat is in Phase 3 clinical development. Two Phase 3 trials have been completed, with a total enrollment of 4,914 patients. These trials were randomized, double-blind, and placebo-controlled, studying the drug in anemic patients with chronic kidney disease, both on and off dialysis.
Roxadustat has been studied in two completed Phase 3 trials. NCT02174627 enrolled 2,781 patients with anemia and CKD not on dialysis, while NCT02174731 enrolled 2,133 patients with anemia and CKD on dialysis. Both trials were randomized, double-blind, and placebo-controlled, conducted across multiple countries.
Roxadustat is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the treatment of anemia in patients with chronic kidney disease. The two Phase 3 trials have been completed, but the drug has not yet received regulatory approval.
Roxadustat is not known to be the same as any other drug. It is a distinct small molecule being developed by AstraZeneca for the treatment of anemia in chronic kidney disease patients. No alternative names for Roxadustat have been reported.