Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AKB-6548 · 7 trials · 5 indications
Change from pre-dose average was calculated by the mid-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits.
Change from pre-dose average was calculated by the end-of-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.
Change from mid-study average was calculated by the end-of-study average minus the mid-study average. The mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.
Hemoglobin (Hgb) response was defined as participants with mean Hgb ≥11.0 grams per deciliter (g/dL) (average of Weeks 19 and 20) or increase in Hgb by ≥ 1.2 g/dL (average of Weeks 19 and 20) over pre-dose average (average of the two Hgb values obtained prior to dosing) without receiving Erythropoiesis-Stimulating Agents (ESA) or transfusion.
Absolute change from Baseline was calculated as the Week 6 (end of treatment) value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing. If there was only one measurement prior to dosing, this measurement served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased.
Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates that hemoglobin concentration increased.
maximum observed plasma concentration (Cmax) for celecoxib
time to reach Cmax for celecoxib
terminal elimination half-life (t½) for celecoxib
concentration (AUC0-t) for celecoxib
area under the plasma concentration-time curve from 0 to last quantifiable
AUC from time 0 to infinity (AUC0-inf) for celecoxib
apparent oral clearance (CL/F) for celecoxib
apparent volume of distribution during the terminal phase (Vz/F) for celecoxib
| Arm | Type | Description |
|---|---|---|
| AKB-6548, starting dose 1 | EXPERIMENTAL | - |
| AKB-6548, starting dose 2 | EXPERIMENTAL | - |
| AKB-6548, starting dose 3 | EXPERIMENTAL | - |
| AKB-6548 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| AKB-6548 240 mg | EXPERIMENTAL | - |
| AKB-6548 370 mg | EXPERIMENTAL | - |
| AKB-6548 500 mg | EXPERIMENTAL | - |
| AKB-6548 630 mg | EXPERIMENTAL | - |
| Celecoxib | ACTIVE_COMPARATOR | Celecoxib |
| AKB-6548 and Celecoxib | EXPERIMENTAL | AKB-6548; celecoxib |
| AKB-6548 plus Ferrous Sulfate | EXPERIMENTAL | AKB-6548 plus ferrous sulfate |
| AKB-6548 (therapeutic dose) | EXPERIMENTAL | - |
| AKB-6548 (supratherapeutic dose) | EXPERIMENTAL | - |
| Moxifloxacin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AKB-6548 | DRUG | Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol. |
| Placebo | DRUG | Oral Placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol. |
| Celecoxib | DRUG | - |
| Ferrous Sulfate | DRUG | - |
| AKB-6548 (therapeutic dose) | DRUG | Single oral dose of AKB-6548 at a therapeutic dose level |
| AKB-6548 (supratherapeutic dose) | DRUG | Single oral dose of AKB-6548 at a supratherapeutic dose level |
| Moxifloxacin | DRUG | Single oral dose of 400 mg moxifloxacin |
Key Inclusion Criteria: * 18 to 79 years inclusive * Chronic Kidney Disease (CKD) Stage 5 on chronic hemodialysis for at least 3 months * Anemia secondary to CKD treated with erythropoiesis stimulating agent and intravenous iron Key Exclusion Criteria: * Body mass index \>44.0 kilograms per meter...
AKB-6548 is an investigational small molecule being developed for the treatment of anemia, including anemia associated with chronic kidney disease and end stage renal disease. It has been studied in healthy volunteers as well. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.
AKB-6548 is being developed by Akebia Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AKBA. The company has conducted multiple clinical trials of AKB-6548 in the United States for the treatment of anemia in patients with kidney disease.
AKB-6548 is currently in Phase 2 clinical development. All four clinical trials of the drug have been completed, with no active trials ongoing. The drug is investigational and has not received FDA approval for any indication.
AKB-6548 has been studied in four completed Phase 2 clinical trials in the United States. These include NCT01235936, NCT01381094, NCT01906489, and NCT02260193, which evaluated the drug in patients with anemia and chronic kidney disease or end stage renal disease requiring hemodialysis. Total enrollment across these trials was 407 participants.
AKB-6548 is the investigational code name for the drug developed by Akebia Therapeutics. The drug has also been referred to by the name vadadustat in clinical and regulatory contexts. Both names refer to the same small molecule compound being studied for the treatment of anemia.