A Phase 2 interventional study of Vadadustat and Placebo in Anemia and Non-dialysis Dependent Chronic Kidney Disease, sponsored by Akebia Therapeutics. Completed at 18 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by Akebia Therapeutics · Phase 2, Interventional, and Treatment
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 Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD).
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 51 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Akebia Therapeutics is the lead sponsor of 34 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Daily oral dose
Drug: Vadadustat
Daily oral dose
Drug: Vadadustat
Daily oral dose
Drug: Vadadustat
Daily oral dose
Drug: Placebo
Also known as: AKB-6548
Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period
The pre-treatment value for Hb was defined as the average of 2 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 6 value minus the Pre-treatment value.
Time frame: Pre-treatment; Week 6
Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16
Time for this analysis was measured from Day 1 (Baseline) through the point in time during either the Primary Efficacy Period or the Dose Adjustment and Maintenance Period when a participant's Hb level achieved the target range of 10.0 to 12.0 g/dL.
Time frame: from Baseline up to Week 16
Mean Hb Levels at the End of the Primary Efficacy Period
Data are reported as mean of the actual Week 6 values.
Time frame: up to Week 6
Mean Hb Levels at the End of the Dose Adjustment and Maintenance Period
Data are reported as mean of the actual Week 16 values.
Time frame: up to Week 16
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
Time frame: up to Week 16
Mean Change in Hb Between Pre-treatment and the End of the Dose Adjustment and Maintenance Period
The pre-treatment value for Hb was defined as the average of 2 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 16 value minus the Pre-treatment value.
Time frame: Pre-treatment; Week 16
Mean Change in Red Blood Cell (RBC) Count and Absolute Reticulocyte Count From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 6
Mean Change in RBC Count and Absolute Reticulocyte Count From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 16
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 6
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 16
Mean Change in Iron and Total Iron Binding Capacity (TIBC) From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 6
Mean Change in Iron and TIBC From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 16
Mean Change in Transferrin Saturation (TSAT) From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 6
Mean Change in TSAT From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 16
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 6
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 16
Number of Participants Who Required Rescue With Erythropoiesis-stimulating Agents (ESAs) From Baseline to the End of the Primary Efficacy Period
ESA rescue is defined as participants with ESA administration and 1) the participant experienced a clinically significant worsening of their anemia or symptoms of anemia, 2) the participant's Hb level is \<9.0 g/dL, and 3) reason for early study withdrawal of worsening of anemia requiring ESA rescue or blood transfusion. Participants who initiated rescue therapy (including ESAs) were required to stop study drug treatment and were discontinued from the study.
Time frame: Baseline; Week 6
Number of Participants Who Required Rescue With ESAs From Baseline to the End of the Dose Adjustment and Maintenance Period
ESA rescue is defined as participants with ESA administration and 1) the participant experienced a clinically significant worsening of their anemia or symptoms of anemia, 2) the participant's Hb level is \<9.0 g/dL, and 3) reason for early study withdrawal of worsening of anemia requiring ESA rescue or blood transfusion. Participants who initiated rescue therapy (including ESAs) were required to stop study drug treatment and were discontinued from the study.
Time frame: Baseline; Week 16
Number of Participants Who Required Rescue With a RBC Transfusion From Baseline to the End of the Primary Efficacy Period
Participants who initiated rescue therapy (including RBC transfusion) were required to stop study drug treatment and were discontinued from the study.
Time frame: Baseline; Week 6
Number of Participants Who Required Rescue With a RBC Transfusion From Baseline to the End of the Dose Adjustment and Maintenance Period
Participants who initiated rescue therapy (including RBC transfusion) were required to stop study drug treatment and were discontinued from the study.
Time frame: Baseline; Week 16
Number of the Participants With the Indicated Number of Dose Adjustments From Baseline to the End of the Dose Adjustment and Maintenance Period
Increases in dose were not allowed during the 6-week Primary Efficacy Period.
Time frame: Baseline to Week 16
Number of Participants Who Maintained Iron Sufficiency From Baseline to Week 6
Iron sufficiency was defined as ferritin ≥50 ng/mL and TSAT ≥20%.
Time frame: Baseline to Week 6
Number of Participants Who Maintained Iron Sufficiency From Baseline to Week 16
Iron sufficiency was defined as ferritin ≥50 ng/mL and TSAT ≥20%.
Time frame: Baseline to Week 16
Plasma Concentration Profile of Vadadustat and Its Metabolites Using a Pre-dose Sample From Week 4
Blood samples were collected for analysis.
Time frame: Week 4, pre-dose
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) in the Primary Efficacy Period
An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. An AE that met one or more of the following criteria or outcomes was classified as serious: death; life-threatening; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/ incapacity; congenital anomaly/birth defect; was considered a medically important event not meeting the above criteria, but which could jeopardize a participant, or could require medical or surgical intervention to prevent one of the criteria listed in this definition.
Time frame: up to Week 6
Number of Participants With TEAEs and Treatment-emergent SAEs in the Dose Adjustment and Maintenance Period
An AE was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. An AE that met one or more of the following criteria or outcomes was classified as serious: death; life-threatening; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; was considered a medically important event not meeting the above criteria, but which could jeopardize a participant, or could require medical or surgical intervention to prevent one of the criteria listed in this definition.
Time frame: up to Week 16
| Milestone | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| Started | 12 | 12 | 13 | 5 | 4 | 5 |
| Completed | 12 | 12 | 13 | 5 | 4 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| Started | 12 | 12 | 13 | 5 | 4 | 5 |
| Completed | 11 | 10 | 12 | 5 | 4 | 4 |
| Not completed | 1 | 2 | 1 | 0 | 0 | 1 |
| Withdrew: Investigator discretion | 1 | 2 | 1 | 0 | 0 | 1 |
The pre-treatment value for Hb was defined as the average of 2 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 6 value minus the Pre-treatment value.
| grams per deciliter (g/dL) | Vadadustat 150 | Vadadustat 300 mg | Vadadustat 600 mg | Placebo |
|---|---|---|---|---|
| Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period | 0.43 ± 0.224 | 1.13 ± 0.223 | 1.62 ± 0.215 | -0.47 ± 0.206 |
Time for this analysis was measured from Day 1 (Baseline) through the point in time during either the Primary Efficacy Period or the Dose Adjustment and Maintenance Period when a participant's Hb level achieved the target range of 10.0 to 12.0 g/dL.
| days | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16 | 56.8 ± 43.31 | 39.0 ± 38.52 | 25.6 ± 16.47 | 79.0 ± 11.31 | 71.0 ± 14.00 | 54.5 ± 33.67 |
Data are reported as mean of the actual Week 6 values.
| g/dL | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo |
|---|---|---|---|---|
| Mean Hb Levels at the End of the Primary Efficacy Period | 10.392 ± 0.7280 | 10.675 ± 1.2693 | 11.162 ± 1.1169 | 9.421 ± 0.9242 |
Data are reported as mean of the actual Week 16 values.
| g/dL | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| Mean Hb Levels at the End of the Dose Adjustment and Maintenance Period | 10.973 ± 0.5711 | 11.230 ± 0.7514 | 11.342 ± 0.6473 | 10.860 ± 0.5857 | 11.425 ± 0.9179 | 11.950 ± 0.6608 |
| Participants | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| 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 | 11 | 8 | 11 | 5 | 3 | 2 |
The pre-treatment value for Hb was defined as the average of 2 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 16 value minus the Pre-treatment value.
| g/dL | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| Mean Change in Hb Between Pre-treatment and the End of the Dose Adjustment and Maintenance Period | 0.982 ± 0.3676 | 1.610 ± 1.1692 | 1.779 ± 0.8117 | 0.790 ± 0.3070 | 1.538 ± 0.5250 | 2.075 ± 0.2784 |
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| 10^6 cells/microliter (μL) | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo |
|---|---|---|---|---|
| RBC Count | 0.17 ± 0.075 | 0.34 ± 0.075 | 0.48 ± 0.073 | -0.17 ± 0.070 |
| Absolute Reticulocyte Count | 0.01 ± 0.004 | 0.01 ± 0.003 | 0.01 ± 0.003 | 0.01 ± 0.003 |
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| 10^6 cells/μL | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| RBC Count | 0.305 ± 0.1870 | 0.476 ± 0.4406 | 0.593 ± 0.3186 | 0.186 ± 0.2165 | 0.438 ± 0.2175 | 0.608 ± 0.1771 |
| Absolute Reticulocyte Count | 0.003078 ± 0.0094008 | 0.008001 ± 0.0156884 | 0.000196 ± 0.0085029 | 0.010716 ± 0.0279909 | 0.009703 ± 0.0103348 | 0.000595 ± 0.0171563 |
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| percentage | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo |
|---|---|---|---|---|
| Hematocrit | 2.13 ± 0.696 | 4.13 ± 0.696 | 6.07 ± 0.667 | -1.17 ± 0.643 |
| Reticulocytes | 0.16 ± 0.111 | 0.28 ± 0.111 | 0.19 ± 0.107 | 0.25 ± 0.103 |
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| percentage | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| Hematocrit | 3.28 ± 1.947 | 5.17 ± 4.991 | 5.39 ± 2.844 | 2.32 ± 1.827 | 5.80 ± 1.566 | 6.05 ± 1.997 |
| Reticulocytes | -0.02 ± 0.232 | 0.07 ± 0.442 | -0.18 ± 0.279 | 0.28 ± 0.893 | 0.15 ± 0.238 | -0.18 ± 0.377 |
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| micrograms per deciliter (μg/dL) | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo |
|---|---|---|---|---|
| Iron | -1.8 ± 19.58 | -2.4 ± 20.75 | 4.4 ± 30.82 | -7.4 ± 19.92 |
| TIBC | 44.9 ± 32.9 | 75.2 ± 35.60 | 93.8 ± 44.74 | 7.6 ± 23.55 |
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| μg/dL | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| Iron | 11.7 ± 38.25 | 3.5 ± 31.17 | 11.5 ± 28.56 | -1.4 ± 21.82 | 5.5 ± 24.66 | 5.8 ± 25.59 |
| TIBC | 51.8 ± 48.41 | 43.4 ± 42.77 | 42.8 ± 28.28 | 47.6 ± 21.71 | 73.5 ± 39.95 | 44.5 ± 43.19 |
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| percentage | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo |
|---|---|---|---|---|
| Mean Change in Transferrin Saturation (TSAT) From Baseline to the End of the Primary Efficacy Period | -4.96 ± 7.343 | -7.31 ± 8.380 | -6.78 ± 10.609 | -4.72 ± 8.931 |
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| percentage | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| Mean Change in TSAT From Baseline to the End of the Dose Adjustment and Maintenance Period | -1.47 ± 10.365 | -2.68 ± 13.201 | -0.19 ± 9.857 | -7.00 ± 12.247 | -5.03 ± 11.342 | -2.68 ± 10.608 |
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| nanograms per milliliter (ng/mL) | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo |
|---|---|---|---|---|
| Ferritin | -38.48 ± 34.227 | -69.36 ± 49.965 | -101.54 ± 57.697 | -11.44 ± 31.408 |
| Hepcidin | -24.622 ± 20.0165 | -40.819 ± 27.2486 | -37.964 ± 21.0819 | -3.824 ± 18.4986 |
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| ng/mL | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| Ferritin | -79.45 ± 39.655 | -62.35 ± 36.808 | -59.68 ± 59.843 | -69.26 ± 46.519 | -146.63 ± 34.261 | -59.43 ± 13.618 |
| Hepcidin | -29.522 ± 22.7101 | -23.061 ± 53.0161 | -2.502 ± 21.2660 | -9.464 ± 19.1361 | -38.920 ± 23.4788 | -9.745 ± 9.2100 |
ESA rescue is defined as participants with ESA administration and 1) the participant experienced a clinically significant worsening of their anemia or symptoms of anemia, 2) the participant's Hb level is \<9.0 g/dL, and 3) reason for early study withdrawal of worsening of anemia requiring ESA rescue or blood transfusion. Participants who initiated rescue therapy (including ESAs) were required to stop study drug treatment and were discontinued from the study.
| Participants | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo |
|---|---|---|---|---|
| Number of Participants Who Required Rescue With Erythropoiesis-stimulating Agents (ESAs) From Baseline to the End of the Primary Efficacy Period | 0 | 0 | 0 | 0 |
ESA rescue is defined as participants with ESA administration and 1) the participant experienced a clinically significant worsening of their anemia or symptoms of anemia, 2) the participant's Hb level is \<9.0 g/dL, and 3) reason for early study withdrawal of worsening of anemia requiring ESA rescue or blood transfusion. Participants who initiated rescue therapy (including ESAs) were required to stop study drug treatment and were discontinued from the study.
| Participants | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| Number of Participants Who Required Rescue With ESAs From Baseline to the End of the Dose Adjustment and Maintenance Period | 0 | 2 | 1 | 0 | 0 | 0 |
Participants who initiated rescue therapy (including RBC transfusion) were required to stop study drug treatment and were discontinued from the study.
| Participants | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo |
|---|---|---|---|---|
| Number of Participants Who Required Rescue With a RBC Transfusion From Baseline to the End of the Primary Efficacy Period | 0 | 0 | 0 | 0 |
Participants who initiated rescue therapy (including RBC transfusion) were required to stop study drug treatment and were discontinued from the study.
| Participants | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| Number of Participants Who Required Rescue With a RBC Transfusion From Baseline to the End of the Dose Adjustment and Maintenance Period | 0 | 1 | 1 | 0 | 0 | 1 |
Increases in dose were not allowed during the 6-week Primary Efficacy Period.
| Participants | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| 0 dose adjustments | 3 | 1 | 2 | 0 | 0 | 1 |
| 1 dose adjustment | 5 | 7 | 1 | 3 | 1 | 1 |
| 2 dose adjustments | 3 | 4 | 3 | 1 | 1 | 2 |
| 3 or more dose adjustments | 1 | 0 | 7 | 1 | 2 | 1 |
Iron sufficiency was defined as ferritin ≥50 ng/mL and TSAT ≥20%.
| Participants | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo |
|---|---|---|---|---|
| Iron sufficiency maintained | 7 | 4 | 4 | 9 |
| Iron sufficiency not maintained | 5 | 8 | 9 | 5 |
Iron sufficiency was defined as ferritin ≥50 ng/mL and TSAT ≥20%.
| Participants | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| Iron sufficiency maintained | 6 | 2 | 4 | 1 | 1 | 0 |
| Iron sufficiency not maintained | 6 | 10 | 9 | 4 | 3 | 5 |
Blood samples were collected for analysis.
| micrograms per milliliter (µg/mL) | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo |
|---|---|---|---|---|
| Vadadustat | 5530.9 ± 4168.86 | 12955.8 ± 9771.65 | 19291.5 ± 9325.30 | — |
| O-glucuronide | 3914.7 ± 5772.39 | 12358.6 ± 7586.73 | 16586.2 ± 12363.44 | — |
| Acyl-glucuronide | 0.00 ± 0.000 | 1.95 ± 6.755 | 8.99 ± 16.430 | — |
An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. An AE that met one or more of the following criteria or outcomes was classified as serious: death; life-threatening; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/ incapacity; congenital anomaly/birth defect; was considered a medically important event not meeting the above criteria, but which could jeopardize a participant, or could require medical or surgical intervention to prevent one of the criteria listed in this definition.
| Participants | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo |
|---|---|---|---|---|
| TEAEs | 4 | 7 | 7 | 5 |
| Treatment-emergent SAEs | 0 | 0 | 0 | 0 |
An AE was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. An AE that met one or more of the following criteria or outcomes was classified as serious: death; life-threatening; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; was considered a medically important event not meeting the above criteria, but which could jeopardize a participant, or could require medical or surgical intervention to prevent one of the criteria listed in this definition.
| Participants | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg |
|---|---|---|---|---|---|---|
| TEAEs | 9 | 10 | 6 | 3 | 3 | 3 |
| Treatment-emergent SAEs | 0 | 5 | 2 | 1 | 1 | 2 |
Collected over up to Week 18. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Primary Efficacy Period: 150 mg Vadadustat | 0/12 (0%) | 0/12 (0%) | 4/12 (33.3%) |
| Primary Efficacy Period: 300 mg Vadadustat | 0/12 (0%) | 0/12 (0%) | 7/12 (58.3%) |
| Primary Efficacy Period: 600 mg Vadadustat | 0/13 (0%) | 0/13 (0%) | 7/13 (53.8%) |
| Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat | 0/5 (0%) | 0/5 (0%) | 3/5 (60%) |
| Dose Adjustment and Maintenance: 150 mg Vadadustat | 0/12 (0%) | 0/12 (0%) | 9/12 (75%) |
| Dose Adjustment and Maintenance: 300 mg Vadadustat | 0/12 (0%) | 5/12 (41.7%) | 10/12 (83.3%) |
| Dose Adjustment and Maintenance: 600 mg Vadadustat | 0/13 (0%) | 2/13 (15.4%) | 6/13 (46.2%) |
| Dose Adjustment and Maintenance: Placebo to 150 mg Vadadustat | 0/5 (0%) | 1/5 (20%) | 2/5 (40%) |
| Dose Adjustment and Maintenance: Placebo to 300 mg Vadadustat | 0/4 (0%) | 1/4 (25%) | 2/4 (50%) |
| Dose Adjustment and Maintenance: Placebo to 600 mg Vadadustat | 0/5 (0%) | 2/5 (40%) | 2/5 (40%) |
| Event | Primary Efficacy Period: 150 mg Vadadustat | Primary Efficacy Period: 300 mg Vadadustat | Primary Efficacy Period: 600 mg Vadadustat | Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat | Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat | Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat | Dose Adjustment and Maintenance: 150 mg Vadadustat | Dose Adjustment and Maintenance: 300 mg Vadadustat | Dose Adjustment and Maintenance: 600 mg Vadadustat | Dose Adjustment and Maintenance: Placebo to 150 mg Vadadustat | Dose Adjustment and Maintenance: Placebo to 300 mg Vadadustat | Dose Adjustment and Maintenance: Placebo to 600 mg Vadadustat |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| InfluenzaInfections and infestations | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 0/12 | 0/13 | 0/5 | 1/4 | 0/5 |
| Arteriovenous shunt procedureSurgical and medical procedures | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 3/12 | 0/13 | 0/5 | 0/4 | 0/5 |
| Duodenal ulcer hemorrhageGastrointestinal disorders | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 1/5 |
| Spinal compression fractureInjury, poisoning and procedural complications | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 0/12 | 0/13 | 1/5 | 0/4 | 0/5 |
| Renal impairmentRenal and urinary disorders | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 1/5 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 1/5 |
| Hepatic function abnormalHepatobiliary disorders | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 1/12 | 0/13 | 0/5 | 0/4 | 0/5 |
| End-stage renal diseaseRenal and urinary disorders | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 1/12 | 0/13 | 0/5 | 0/4 | 0/5 |
| Lung infectionInfections and infestations | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 0/12 | 1/13 | 0/5 | 0/4 | 0/5 |
| Acute kidney injuryRenal and urinary disorders | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 0/12 | 1/13 | 0/5 | 0/4 | 0/5 |
| Event | Primary Efficacy Period: 150 mg Vadadustat | Primary Efficacy Period: 300 mg Vadadustat | Primary Efficacy Period: 600 mg Vadadustat | Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat | Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat | Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat | Dose Adjustment and Maintenance: 150 mg Vadadustat | Dose Adjustment and Maintenance: 300 mg Vadadustat | Dose Adjustment and Maintenance: 600 mg Vadadustat | Dose Adjustment and Maintenance: Placebo to 150 mg Vadadustat | Dose Adjustment and Maintenance: Placebo to 300 mg Vadadustat | Dose Adjustment and Maintenance: Placebo to 600 mg Vadadustat |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Viral upper respiratory tract infectionInfections and infestations | 0/12 | 1/12 | 0/13 | 0/5 | 1/4 | 0/5 | 1/12 | 1/12 | 1/13 | 1/5 | 0/4 | 0/5 |
| HypertensionVascular disorders | 0/12 | 3/12 | 2/13 | 0/5 | 0/4 | 0/5 | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 |
| StomatitisGastrointestinal disorders | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 0/12 | 0/13 | 0/5 | 1/4 | 0/5 |
| CystitisInfections and infestations | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 0/12 | 0/13 | 0/5 | 1/4 | 0/5 |
| DizzinessNervous system disorders | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 0/12 | 0/13 | 0/5 | 1/4 | 0/5 |
| Loss of consciousnessNervous system disorders | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 0/12 | 0/13 | 0/5 | 1/4 | 0/5 |
| Uterine prolapseReproductive system and breast disorders | 0/12 | 0/12 | 0/13 | 0/5 | 1/4 | 0/5 | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 |
| ConstipationGastrointestinal disorders | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 2/12 | 0/13 | 0/5 | 0/4 | 1/5 |
| DiarrhoeaGastrointestinal disorders | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 0/5 | 0/12 | 1/12 | 1/13 | 1/5 | 0/4 | 0/5 |
| Oedema due to renal diseaseGeneral disorders | 1/12 | 0/12 | 0/13 | 0/5 | 0/4 | 1/5 | 0/12 | 0/12 | 0/13 | 0/5 | 0/4 | 1/5 |
Baseline data are reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of study medication. The Safety Population was based on the actual treatment that participants received.
| Age, Continuous(years) | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg | Total |
|---|---|---|---|---|---|---|---|
| Mean | 71.9 ± 10.33 | 65.8 ± 11.53 | 71.5 ± 12.84 | 73.4 ± 3.05 | 68.0 ± 21.21 | 72.2 ± 8.64 | 70.2 ± 11.55 |
| Sex: Female, Male(Participants) | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg | Total |
|---|---|---|---|---|---|---|---|
| Female | 5 | 5 | 8 | 1 | 1 | 2 | 22 |
| Male | 7 | 7 | 5 | 4 | 3 | 3 | 29 |
| Race and Ethnicity Not Collected(Participants) | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg | Total |
|---|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | — | 0 |
| Hemoglobin Levels(grams per deciliter (g/dL)) | Vadadustat 150 mg | Vadadustat 300 mg | Vadadustat 600 mg | Placebo to Vadadustat 150 mg | Placebo to Vadadustat 300 mg | Placebo to Vadadustat 600 mg | Total |
|---|---|---|---|---|---|---|---|
| Mean | 9.958 ± 0.8051 | 9.492 ± 0.8867 | 9.500 ± 0.8446 | 10.280 ± 0.9365 | 9.625 ± 0.6551 | 9.680 ± 0.8198 | 9.710 ± 0.8410 |
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Akebia Therapeutics