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

Akebia Therapeutics

Status and phase: Suspended; Phase 3

Conditions: Anemia of Chronic Kidney Disease

Treatments: Drug: vadadustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT05082571

AKB-6548-CI-0041

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) after conversion from an Erythropoiesis Stimulating Agent (ESA).

Enrollment: 71 estimated patients

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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

71 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