A study to evaluate the effectiveness and safety of a study drug called vadadustat in the maintenance treatment of anemia for children, after they've converted from ESA therapy
- Conditions
- Anemia of Chronic kidney disease (CKD)MedDRA version: 20.0Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 100000004851MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2021-004022-30-ES
- Lead Sponsor
- Akebia Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- 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 hemoglobin (Hb) between 9.0 and 12.0 grams/deciliters (g/dL) (inclusive)
*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
- Secondary Outcome Measures
Name Time Method