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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | Luspatercept |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Disc Medicine, Inc. | IRON | 2 | PHASE2 | DISC-0974 |
| Akebia Therapeutics, Inc. | AKBA | 2 | PHASE3 | Vadadustat |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
| Bayer | BAYRY | 1 | - | Molidustat |
Roxadustat is being developed for the treatment of anemia in patients with chronic kidney disease. It is a small molecule studied in both dialysis-dependent and non-dialysis chronic kidney disease populations. It is an investigational therapy and has not been approved by the FDA.
Roxadustat targets the EGLN1, EGLN2, EGLN3, and P4HTM proteins and acts as an inhibitor of these targets. By inhibiting these enzymes, it is designed to stimulate erythropoiesis, the production of red blood cells, which is relevant to treating anemia in chronic kidney disease.
Roxadustat is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is the sponsor behind the clinical development program for this small molecule in anemia associated with chronic kidney disease.
Roxadustat is in Phase 3 clinical development. It is an investigational drug and is not FDA approved. The Phase 3 program includes two completed trials that together enrolled 4,914 patients, and both studies were randomized, double-blind, and placebo-controlled.
Roxadustat has been studied in two completed Phase 3 trials. NCT02174731 evaluated its safety and efficacy in anemia patients with chronic kidney disease who are on dialysis, enrolling 2,133 patients. NCT02174627 evaluated anemia in chronic kidney disease patients not on dialysis, enrolling 2,781 patients.
Roxadustat is an investigational oral small molecule being studied to treat anemia in patients with chronic kidney disease. Its Phase 3 trials covered both patients on dialysis and patients not on dialysis, with anemia as the condition under study in each trial.