Back to resultsStudy to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents (CORRECTION)
Primary Purpose
Anemia of Chronic Kidney Disease
Status
Suspended
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vadadustat
Sponsored by
About this trial
This is an interventional treatment trial for Anemia of Chronic Kidney Disease focused on measuring anemia, chronic kidney disease, erythropoiesis stimulating agent, dialysis, vadadustat, pediatric population, children, kidney disease, hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor
Eligibility 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 (<) 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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vadadustat
Arm Description
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
Outcomes
Primary Outcome Measures
Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28)
Secondary Outcome Measures
Time to Achieve First Hb Levels ≥10.0 grams/deciliters (g/dL)
Number of Participants With Mean Hb Values Within the Target Range During the Primary Evaluation Period
Number of Participants With Mean Hb Values Within the Target Range During the Extension Period
Number of Participants With Treatment-emergent Adverse Events and who Discontinued From the Study due to Adverse Events
Maximum Observed Plasma Concentration (Cmax) of Vadadustat and its Metabolites
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC 0-t) of Vadadustat and its Metabolites
Time to Reach Cmax (Tmax) of Vadadustat and its Metabolites
Terminal Elimination Half-Life (t1/2) of Vadadustat and its Metabolites
Change From Baseline in Serum Erythropoietin (EPO)
Change From Baseline in Reticulocyte Count
Change From Baseline in Hb levels
Full Information
NCT ID
NCT05082584
First Posted
September 28, 2021
Last Updated
October 9, 2023
Sponsor
Akebia Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT05082584
Brief Title
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents
Acronym
CORRECTION
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
Recruitment temporarily halted to reassess the development plan.
Study Start Date
January 2025 (Anticipated)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akebia Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Chronic Kidney Disease
Keywords
anemia, chronic kidney disease, erythropoiesis stimulating agent, dialysis, vadadustat, pediatric population, children, kidney disease, hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vadadustat
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Vadadustat
Other Intervention Name(s)
AKB-6548
Intervention Description
Vadadustat tablet orally once a day for 52 weeks
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Time to Achieve First Hb Levels ≥10.0 grams/deciliters (g/dL)
Time Frame
Up to Week 52
Title
Number of Participants With Mean Hb Values Within the Target Range During the Primary Evaluation Period
Time Frame
From Week 21 to Week 28
Title
Number of Participants With Mean Hb Values Within the Target Range During the Extension Period
Time Frame
From Week 29 to Week 52
Title
Number of Participants With Treatment-emergent Adverse Events and who Discontinued From the Study due to Adverse Events
Time Frame
Up to Week 56
Title
Maximum Observed Plasma Concentration (Cmax) of Vadadustat and its Metabolites
Time Frame
Pre-dose and post-dose at intermediate time points up to 28 weeks
Title
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC 0-t) of Vadadustat and its Metabolites
Time Frame
Pre-dose and post-dose at intermediate time points up to 28 weeks
Title
Time to Reach Cmax (Tmax) of Vadadustat and its Metabolites
Time Frame
Pre-dose and post-dose at intermediate time points up to 28 weeks
Title
Terminal Elimination Half-Life (t1/2) of Vadadustat and its Metabolites
Time Frame
Pre-dose and post-dose at intermediate time points up to 28 weeks
Title
Change From Baseline in Serum Erythropoietin (EPO)
Time Frame
Pre-dose and post-dose at intermediate time points up to 28 weeks
Title
Change From Baseline in Reticulocyte Count
Time Frame
Pre-dose and post-dose at intermediate time points up to 28 weeks
Title
Change From Baseline in Hb levels
Time Frame
Pre-dose and post-dose at intermediate time points up to 28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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 (<) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Akebia Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents
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