Phase 2
Completed N=10
Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Source: ClinicalTrials.gov NCT01235936 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Mean Change From Baseline in Hemoglobin (Hgb) on Day 29 — 9.91; 0.63 Grams per decilitre (g/dL) — p=0.0020
Summary
The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Hemoglobin (Hgb) on Day 29 |
9.91; 0.63 | 0.0020 sig |
| SECONDARY Mean Change From Baseline in Hematocrit on Day 29 |
30.43; 1.62 | =0.0156 sig |
| SECONDARY Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29 |
3.313; 0.167 | 0.0098 sig |
| SECONDARY Mean Change From Baseline in Absolute Reticulocyte Count on Day 29 |
51076.00; 18647.00 | =0.0195 sig |
| SECONDARY Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29 |
31.49; 0.13 | =0.8262 |
| SECONDARY Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29 |
6; 5; 3; 2 | — |
| SECONDARY Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29 |
5; 3; 3 | — |
| SECONDARY Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29 |
6; 2; 2 | — |
| SECONDARY Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29 |
5; 3; 3 | — |
| SECONDARY Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29 |
8; 7; 6 | — |
| SECONDARY Change From Baseline in Ferritin on Day 29 |
324.0; -52.3 | =0.0020 sig |
| SECONDARY Change From Baseline in Iron on Day 29 |
69.4; -8.2 | =0.2383 |
| SECONDARY Change From Baseline in Total Iron Binding Capacity on Day 29 |
266.4; 43.4 | =0.0039 sig |
| SECONDARY Change From Baseline in Transferrin Saturation on Day 29 |
26.1; -6.4 | =0.0039 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
5; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values |
— | — |
| SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values |
— | — |
| SECONDARY Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings |
— | — |
| SECONDARY Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval |
183.2; -4.4; 415.6; 1.4; 95.4; 3.4 | — |
| SECONDARY Mean Trough Concentrations of Vadadustat at Day 8, 15, 22 and 29 |
3260.6; 3826.3; 3667.4; 5622.4 | — |
Eligibility Criteria
Key Inclusion Criteria
- 18 to 79 years of age, inclusive
- Chronic Kidney Disease Stage 3 or Stage 4
- Hemoglobin (Hgb) 20% and CBC indicating normocytic red blood cell morphology
Key Exclusion Criteria
- BMI > 40
- Red blood cell transfusion within 12 weeks.
- Androgen therapy within the previous 21 days prior to study dosing
- Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 10 weeks prior to the Screening visit
- Participants meeting the criteria of ESA resistance within the previous 4 months
- Individual doses of intravenous iron of 250 mg or larger within the past 21 days
- AST or ALT >1.8x ULN.
- Alkaline phosphatase >2x ULN.
- Total bilirubin >1.5x ULN.
- Uncontrolled hypertension
- New York Heart Association Class III or IV congestive heart failure
- Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing
Data sourced from ClinicalTrials.gov (NCT01235936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.