Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents (CORRECTION)

Akebia Therapeutics

Status and phase: Withdrawn; Phase 3

Conditions: Anemia of Chronic Kidney Disease

Treatments: Drug: Vadadustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT05082584

AKB-6548-CI-0042

Details and patient eligibility

About

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) naive to erythropoiesis-stimulating agent (ESA) treatment.

Sex: All

Ages: 4 months to 16 years old

Volunteers: No Healthy Volunteers

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 screening hemoglobin (Hb) <10.0 grams/deciliters (g/dL)
• Transferrin Saturation ≥ 20%

Exclusion criteria

• Anemia due to a cause other than CKD
• Active bleeding or recent clinically significant blood loss
• Treatment with an erythropoiesis-stimulating agents (ESA) within 8 weeks prior to Screening
• 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 <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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Vadadustat

Experimental group

Description:

Cohort 1: participants with ≥12 years to \<17 years; Cohort 2: participants with ≥6 years to \<12 years; Cohort 3(a): participants with ≥2 years to \<6 years; and Cohort 3(b): participants with ≥4 months to \<2 years

Treatment:

Drug: Vadadustat