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

Anemia of Chronic Kidney Disease Clinical Trial

— CORRECTION  

Official title:

A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Once Daily Oral Vadadustat for The Treatment of Pediatric Subjects With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-stimulating Agents

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05082584
• Other study ID #: AKB-6548-CI-0042
• Status: Suspended
• Phase: Phase 3
• Start date: January 2025
• Est. completion date: October 2026

Study information

• Verified date: October 2023
• Source: Akebia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 71
• Est. completion date: October 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia of Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Vadadustat
Vadadustat tablet orally once a day for 52 weeks

Locations

Country	Name	City	State
United States	Research Site	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Akebia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Achieve First Hb Levels =10.0 grams/deciliters (g/dL)		Up to Week 52
Secondary	Number of Participants With Mean Hb Values Within the Target Range During the Primary Evaluation Period		From Week 21 to Week 28
Secondary	Number of Participants With Mean Hb Values Within the Target Range During the Extension Period		From Week 29 to Week 52
Secondary	Number of Participants With Treatment-emergent Adverse Events and who Discontinued From the Study due to Adverse Events		Up to Week 56
Secondary	Maximum Observed Plasma Concentration (Cmax) of Vadadustat and its Metabolites		Pre-dose and post-dose at intermediate time points up to 28 weeks
Secondary	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
Secondary	Time to Reach Cmax (Tmax) of Vadadustat and its Metabolites		Pre-dose and post-dose at intermediate time points up to 28 weeks
Secondary	Terminal Elimination Half-Life (t1/2) of Vadadustat and its Metabolites		Pre-dose and post-dose at intermediate time points up to 28 weeks
Secondary	Change From Baseline in Serum Erythropoietin (EPO)		Pre-dose and post-dose at intermediate time points up to 28 weeks
Secondary	Change From Baseline in Reticulocyte Count		Pre-dose and post-dose at intermediate time points up to 28 weeks
Secondary	Change From Baseline in Hb levels		Pre-dose and post-dose at intermediate time points up to 28 weeks