Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Phase 3

Withdrawn

• Conditions: Anemia; Dialysis-Dependent Chronic Kidney Disease
• Interventions: Drug: Darbepoetin alfa; Drug: Vadadustat

• Registration Number: NCT03242967
• Lead Sponsor: Akebia Therapeutics

Brief Summary

This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08
• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-08
• Primary Completion: 2018-02-12
• Study Completion: 2018-02-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male and female subjects ≥18 years of age
• Receiving chronic maintenance in-center hemodialysis (3 times per week) for end-stage kidney disease
• Currently maintained on ESA therapy
• Mean screening Hb between 8.0 and 11.0 g/dL (inclusive)

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Exclusion Criteria

• Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss
• Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
• Red blood cell transfusion within 4 weeks prior to or during screening
• Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Darbepoetin alfa	Darbepoetin alfa	subcutaneous or intravenous
Vadadustat	Vadadustat	Oral tablet

Primary Outcome Measures

Name	Time	Method
Mean change in Hb between baseline and the primary evaluation period	Baseline visit, Week 36	Mean change in hemoglobin will be evaluated

Secondary Outcome Measures

Name	Time	Method
Mean change in Hb between baseline and the secondary evaluation period	Baseline visit, Week 52	Mean change in hemoglobin will be evaluated
Proportion of subjects with mean Hb within the target range during the primary evaluation period	Baseline visit, Week 36	Hemoglobin values within the target range will be evaluated
Adverse Events (AEs) and Serious Adverse Events (SAEs)	52 weeks	Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated

Trial Locations

Locations (1)

Research Site; 🇺🇸 Northridge, California, United States