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A study to evaluate the effectiveness and safety of a study drug called vadadustat in the maintenance treatment of anemia for children, naïve to ESA therapy

Phase 1
Conditions
Anemia of Chronic kidney disease (CKD)
MedDRA version: 20.0Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 100000004851
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders
Registration Number
EUCTR2021-003994-72-HU
Lead Sponsor
Akebia Therapeutics, Inc.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
71
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%
Are the trial subjects under 18? yes
Number of subjects for this age range: 71
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: The primary objective of the trial is to assess the safety and efficacy of once daily (QD) dosing of vadadustat for the treatment of pediatric subjects with anemia of Chronic Kidney Disease (CKD) naïve to ESA treatment.;Secondary Objective: The secondary objective of the trial is to assess the Pharmacokinetics (PK) and Pharmacodynamics (PD) of vadadustat administered QD dosing in pediatric subjects with anemia of CKD;Primary end point(s): Efficacy endpoints: Mean change in Hb values between Baseline (average pretreatment Hb) and the Primary Evaluation Period (average Hb from Weeks 21 to 28) <br>;Timepoint(s) of evaluation of this end point: Efficacy timepoints : Weeks 21 to 28 inclusive
Secondary Outcome Measures
NameTimeMethod
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