Phase 2
N=60
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
Anemia · Dialysis Dependent Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT03054350 ↗Enrolled (actual)
60
Serious AEs
5.8%
Results posted
Apr 2021
Primary outcome: Primary: Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period — -0.28; 0.08; 0.41; -1.48 grams per deciliter (g/dL) — p=0.0004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vadadustat (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Akebia Therapeutics
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period |
-0.28; 0.08; 0.41; -1.48 | 0.0004 sig |
| SECONDARY Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16 |
69.3; 79.2; 54.6; 57.0; 85.0 | — |
| SECONDARY Mean Hb Levels at the End of the Primary Efficacy Period |
9.064; 9.062; 9.969; 7.817 | — |
| SECONDARY Mean Hb Levels at the End of the Dose Adjustment and Maintenance Period |
10.460; 11.285; 11.100; 8.600; 13.200; 12.100 | — |
| SECONDARY Number of Participants Who Achieved the Target Hb Level of 10.0 to 12.0 g/dL at the End of the Dose Adjustment and Maintenance Period |
7; 11; 7; 0; 0; 1 | — |
| SECONDARY Mean Change in Hb Between Pre-treatment and the End of the Dose Adjustment and Maintenance Period |
1.397; 2.444; 1.644; -0.233; 3.800; 3.000 | — |
| SECONDARY Mean Change in Red Blood Cell (RBC) Count and Absolute Reticulocyte Count From Baseline to the End of the Primary Efficacy Period |
-0.01; 0.08; 0.20; -0.30; 0.02; 0.02 | 0.0232 sig |
| SECONDARY Mean Change in RBC Count and Absolute Reticulocyte Count From Baseline to the End of the Dose Adjustment and Maintenance Period |
0.454; 0.819; 0.503; 0.065; 1.160; 1.035 | — |
| SECONDARY Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period |
0.67; 1.98; 3.30; -2.63; 0.64; 0.57 | 0.0154 sig |
| SECONDARY Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Dose Adjustment and Maintenance Period |
5.12; 8.92; 5.63; 1.20; 12.90; 10.70 | — |
| SECONDARY Mean Change in Iron and Total Iron Binding Capacity (TIBC) From Baseline to the End of the Primary Efficacy Period |
-3.3; -1.5; -8.1; -1.5; 35.4; 67.5 | 0.9373 |
| SECONDARY Mean Change in Iron and TIBC From Baseline to the End of the Dose Adjustment and Maintenance Period |
-18.5; -8.7; 0.9; -9.5; -7.0; 15.0 | — |
| SECONDARY Mean Change in Transferrin Saturation (TSAT) From Baseline to the End of the Primary Efficacy Period |
-6.51; -10.14; -12.46; -2.78 | 0.2708 |
| SECONDARY Mean Change in TSAT From Baseline to the End of the Dose Adjustment and Maintenance Period |
-14.25; -13.79; -10.93; -12.50; -17.10; -4.70 | — |
| SECONDARY Mean Change in Ferritin and Hepcidin From Baseline to the End of the Primary Efficacy Period |
-51.20; -68.67; -104.49; 12.63; -53.465; -73.587 | 0.0207 sig |
| SECONDARY Mean Change in Ferritin and Hepcidin From Baseline to the End of the Dose Adjustment and Maintenance Period |
-105.09; -119.28; -113.52; -43.05; -150.70; -76.95 | — |
| SECONDARY Number of Participants Who Required Rescue With a RBC Transfusion From Baseline to the End of the Primary Efficacy Period |
0; 0; 1; 3 | — |
| SECONDARY Number of Participants Who Required Rescue With RBC Transfusion From Baseline to the End of the Dose Adjustment and Maintenance Period |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Required Rescue With Erythropoiesis-Stimulating Agents (ESAs) From Baseline to the End of the Primary Efficacy Period |
4; 2; 1; 8 | — |
| SECONDARY Number of Participants Who Required Rescue With ESAs From Baseline to the End of the Dose Adjustment and Maintenance Period |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of the Participants With the Indicated Number of Dose Adjustments From Baseline to the End of the Dose Adjustment and Maintenance Period |
5; 3; 9; 2; 3; 3 | — |
| SECONDARY Plasma Concentration Profile of Vadadustat and Its Metabolites Using a Pre-dose Sample From Week 4 |
4343.54; 7561.36; 15083.03; 8667.97; 14623.89; 36476.33 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) in the Primary Efficacy Period |
8; 11; 6; 6; 0; 0 | — |
| SECONDARY Number of Participants With TEAEs and Treatment-emergent SAEs in the Dose Adjustment and Maintenance Period |
9; 9; 9; 1; 1; 2 | — |
Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Dialysis-dependent Chronic Kidney Disease (DD-CKD).
Eligibility Criteria
Inclusion Criteria
- Male and female Japanese participants ≥20 years of age
- Receiving chronic maintenance hemodialysis for end-stage kidney disease
- Hemoglobin (Hb) <10.0 grams per deciliter (g/dL)
Exclusion Criteria
- Anemia due to a cause other than chronic kidney disease (CKD) or presence of active bleeding or recent blood loss
- Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
- Red blood cell transfusion within 4 weeks prior to or during screening
- Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation
Data sourced from ClinicalTrials.gov (NCT03054350). 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.