Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease

Akebia Therapeutics

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Anemia of Chronic Kidney Disease

Interventions

vadadustatDRUG

Vadadustat tablet orally once a day for 52 weeks

Eligibility

Sex: ALLMin age: 4 MonthsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Hackensack, New Jersey, United States

Outcomes

Primary Outcomes

Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28)

Time frame: Baseline; Weeks 21 to 28

Secondary Outcomes

Time to Achieve Hb Levels of ≥10.0 grams/deciliters (g/dL)

Time frame: Up to Week 52

Number of Participants With Mean Hb Values Within the Target Range During the Primary Evaluation Period

Time frame: From Week 21 to Week 28

Number of Participants With Mean Hb Values Within the Target Range During the Extension Period

Time frame: From Week 29 to Week 52

Number of Participants With Treatment-emergent Adverse Events and who Discontinued From the Study due to Adverse Events

Time frame: Up to Week 56

Maximum Observed Plasma Concentration (Cmax) of Vadadustat and its Metabolites

Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks

Time to Reach Cmax (Tmax) of Vadadustat and its Metabolites

Time frame: 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

Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks

Terminal Elimination Half-Life (t1/2) of Vadadustat and its Metabolites

Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks

Data from ClinicalTrials.gov

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