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
- Conditions
- Anemia of Chronic kidney disease (CKD)MedDRA version: 20.0Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 100000004851Therapeutic 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
*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
*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
Name Time Method 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
Name Time Method