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Hypoxia-Inducible Factor (HIF) Prolyl Hydroxylase Inhibitor
vadadustat for Anemia of Chronic Kidney Disease (CONVERSION Trial)
Phase 3
Waitlist Available
Research Sponsored by Akebia Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 29 to week 52
Awards & highlights
CONVERSION Trial 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) after conversion from an Erythropoiesis Stimulating Agent (ESA).
Eligible Conditions
- Anemia of Chronic Kidney Disease
CONVERSION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCONVERSION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week 29 to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 29 to week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC 0-t) of Vadadustat and its Metabolites
Change From Baseline in Hb levels
Change From Baseline in Reticulocyte Count
+8 moreCONVERSION Trial Design
1Treatment groups
Experimental Treatment
Group I: VadadustatExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
vadadustat
2018
Completed Phase 2
~550
Find a Location
Who is running the clinical trial?
Akebia TherapeuticsLead Sponsor
33 Previous Clinical Trials
10,288 Total Patients Enrolled
1 Trials studying Anemia of Chronic Kidney Disease
71 Patients Enrolled for Anemia of Chronic Kidney Disease
Chief Medical OfficerStudy DirectorAkebia Therapeutics Inc.
122 Previous Clinical Trials
21,453 Total Patients Enrolled
1 Trials studying Anemia of Chronic Kidney Disease
71 Patients Enrolled for Anemia of Chronic Kidney Disease
Frequently Asked Questions
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