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

Akebia Therapeutics

Status and phase: Withdrawn; Phase 3

Conditions: Anemia; Dialysis-Dependent Chronic Kidney Disease

Treatments: Drug: Darbepoetin alfa; Drug: Vadadustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03242967

AKB-6548-CI-0023

Details and patient eligibility

About

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)

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Vadadustat

Experimental group

Description:

Oral tablet

Treatment:

Drug: Vadadustat

Darbepoetin alfa

Active Comparator group

Description:

subcutaneous or intravenous

Treatment:

Drug: Darbepoetin alfa