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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02260193 | 16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis | PHASE2 | COMPLETED | 94 | — | — | Sep 10, 2014 | Jul 22, 2015 | Jul 1, 2022 | 16 | United States |
| NCT01906489 | 20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia | PHASE2 | COMPLETED | 210 | — | — | Jul 23, 2013 | Sep 3, 2014 | Jul 21, 2022 | 47 | United States |
| NCT01381094 | 42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia | PHASE2 | COMPLETED | 93 | — | — | Jun 15, 2011 | Feb 16, 2012 | Jul 1, 2022 | 28 | United States |
| NCT01235936 | Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia | PHASE2 | COMPLETED | 10 | — | — | Oct 21, 2010 | May 1, 2011 | Jul 1, 2022 | 2 | United States |
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...