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Clinical Trials/NCT05082584
NCT05082584WithdrawnPhase 3

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

Akebia Therapeutics1 site in 1 country71 target enrollmentStarted: January 1, 2025Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Withdrawn
Enrollment
71
Locations
1
Primary Endpoint
Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
4 Months to 16 Years (Child)
Sex
All
Accepts 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 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

Arms & Interventions

Vadadustat

Experimental

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

Intervention: Vadadustat (Drug)

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

  • Number of Participants With Mean Hb Values Within the Target Range During the Extension Period(From Week 29 to Week 52)
  • 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 Achieve First Hb Levels ≥10.0 grams/deciliters (g/dL)(Up to Week 52)
  • 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 Treatment-emergent Adverse Events and who Discontinued From the Study due to Adverse Events(Up to Week 56)
  • 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)
  • Time to Reach Cmax (Tmax) of Vadadustat and its Metabolites(Pre-dose and post-dose at intermediate time points up to 28 weeks)
  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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