Anemia of Chronic kidney disease (CKD) MedDRA version: 20.0 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 100000004851 MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
Akebia Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) after conversion from an ESA.;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) ;Timepoint(s) of evaluation of this end point: Efficacy timepoints : Weeks 21 to 28 inclusive | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints : *Time to achieve Hb =10.0 g/dL *Proportion of subjects with mean Hb values within the target (=10.0 to <12.0 g/dL) during the Primary Evaluation Period (Weeks 21 to 28) *Proportion of subjects with mean Hb values within the target (=10.0 to <12.0 g/dL) during the Extension Period (Weeks 29 to 52) Safety and Tolerability endpoints: *Frequency and severity of AEs, SAEs, and discontinuation from the study due to AEs *Clinically significant changes from Baseline on vital signs, body weight, height, clinical laboratory tests (hematology, serum chemistry, iron indices), and ECG *Adrenal function assessed by adrenocorticotropic hormone (ACTH) stimulation testing and/or morning (AM) cortisol levels PK/PD endpoints: *Determination of plasma concentrations of vadadustat and metabolites for estimation of PK parameters. A population PK (POPPK) model may be constructed and, if so, reported separately. *Changes in serum EPO, reticulocyte count, and Hb as indices of HIF activity Exploratory endpoints: *Mean change from Baseline to Primary Evaluation Period and End of Treatment (EOT) Visit or Early Termination (ET) Visit in Pediatric Quality of Life Inventory™ (PedsQL) 4.0 Generic Core scores for all subjects and/or parent/legal guardian and for PedsQL 3.0 endstage renal disease (ESRD) Module scores in dialysis subjects and/or parent/legal guardian *Change in biomarkers hepcidin and vascular endothelial growth factor (VEGF);Timepoint(s) of evaluation of this end point: Efficacy endpoints : Weeks 21 to weeks 52 inclusive | — |
Countries
France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United States
Contacts
Public ContactClinical Trial Management
Medpace
Outcome results
None listed