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Also known as AKB-6548, AKB-6548 (therapeutic dose)
AKB-6548, reference formulation given · 4 trials · 4 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.
| 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 | - |
| 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. |
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...
| 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 |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE2 | HEC53856 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
| Bayer | BAYRY | 1 | - | Molidustat |
AKB-6548 is an investigational oral small molecule being studied for the treatment of anemia in patients with chronic kidney disease and in patients with end stage renal disease requiring chronic hemodialysis. It is being developed by Akebia Therapeutics, Inc. (ticker: AKBA) and has been evaluated in Phase 2 clinical trials.
AKB-6548 targets hypoxia-inducible factor, or HIF. It is a small molecule that acts on the hypoxia-inducible factor pathway, a target class involved in the body's response to low oxygen levels. This mechanism is being investigated for its potential to stimulate red blood cell production in anemia associated with kidney disease.
AKB-6548 is being developed by Akebia Therapeutics, Inc., which trades under the ticker symbol AKBA. The company has sponsored Phase 2 clinical trials of the drug in anemia associated with chronic kidney disease and end stage renal disease.
AKB-6548 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. All four of its completed trials were Phase 2 studies, and there are currently no active trials listed for this drug.
AKB-6548 has been studied in four completed Phase 2 trials: NCT02260193 in end stage renal disease requiring chronic hemodialysis, NCT01906489 and NCT01381094 in chronic kidney disease with anemia, and NCT01235936 in chronic kidney disease and anemia. These trials enrolled a total of 407 participants.
Yes, AKB-6548 is also referred to as the AKB-6548 tablet, the reference formulation given in the fasted state, and AKB-6548 at the therapeutic dose. These names all refer to the same investigational small molecule developed by Akebia Therapeutics for anemia in kidney disease.