Anemia of Chronic Kidney Disease
Conditions
Keywords
anemia, kidney disease, vadadustat, pediatric population, children, chronic kidney disease, erythropoiesis stimulating agent, dialysis, hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor
Brief summary
This study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of Chronic Kidney Disease (CKD) after conversion from an Erythropoiesis Stimulating Agent (ESA).
Interventions
DRUGvadadustat
Vadadustat tablet orally once a day for 52 weeks
Sponsors
Akebia Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Months to 16 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of anemia of chronic kidney disease (CKD) * Diagnosis of non-dialysis-dependent (NDD) CKD with an estimated glomerular filtration rate of greater than (\>) 10 and less than (\<) 60 milliliters/minute/1.73 meters\^2 (mL/min/1.73 m\^2) or diagnosis of dialysis dependent (DD) CKD * Mean hemoglobin (Hb) between 9.0 and 12.0 grams/deciliters (g/dL) (inclusive) * Transferrin Saturation ≥ 20%
Exclusion criteria
* Anemia due to a cause other than CKD * Active bleeding or recent clinically significant blood loss * History of sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia * Red Blood Cells transfusion within 4 weeks * Serum albumin level less than 2.5 g/dL * Uncontrolled hypertension * Active malignancy or treatment for malignancy within the past 2 years prior to Screening * Evidence of iron overload or diagnosis of hemochromatosis * Known hypersensitivity to vadadustat or any excipients in vadadustat tablet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28) | Baseline; Weeks 21 to 28 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Mean Hb Values Within the Target Range During the Primary Evaluation Period | From Week 21 to Week 28 |
| Number of Participants With Mean Hb Values Within the Target Range During the Extension Period | From Week 29 to Week 52 |
| Number of Participants With Treatment-emergent Adverse Events and who Discontinued From the Study due to Adverse Events | Up to Week 56 |
| Maximum Observed Plasma Concentration (Cmax) of Vadadustat and its Metabolites | Pre-dose and post-dose at intermediate time points up to 28 weeks |
| Time to Reach Cmax (Tmax) of Vadadustat and its Metabolites | Pre-dose and post-dose at intermediate time points up to 28 weeks |
| Time to Achieve Hb Levels of ≥10.0 grams/deciliters (g/dL) | Up to Week 52 |
| Terminal Elimination Half-Life (t1/2) of Vadadustat and its Metabolites | Pre-dose and post-dose at intermediate time points up to 28 weeks |
| Change From Baseline in Serum Erythropoietin (EPO) | Pre-dose and post-dose at intermediate time points up to 28 weeks |
| Change From Baseline in Reticulocyte Count | Pre-dose and post-dose at intermediate time points up to 28 weeks |
| Change From Baseline in Hb levels | Pre-dose and post-dose at intermediate time points up to 28 weeks |
| Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC 0-t) of Vadadustat and its Metabolites | Pre-dose and post-dose at intermediate time points up to 28 weeks |
Countries
United States
Outcome results
None listed