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, Randomized, Open Label, Active Controlled Study Evaluating the Efficacy and Safety of Three Times Per Week (TIW) Oral Dosing of Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (TRILO2GY)

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03242967

Acronym

TRILOGY

Enrollment

Registered

2017-08-08

Start date

2017-08-31

Completion date

2018-02-12

Last updated

2018-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Dialysis-Dependent Chronic Kidney Disease

Keywords

Anemia, hemoglobin, darbepoetin alfa, TIW, hypoxia-inducible factor prolyl-hydroxylase inhibitor, HIF-PHI, AKB-6548, vadadustat, renal, hypoxia-inducible factor, HIF, dialysis-dependent chronic kidney disease, CKD, DD-CKD, kidney, erythropoiesis stimulating agent, ESA

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)

Interventions

DRUGVadadustat

Oral tablet

DRUGDarbepoetin alfa

subcutaneous or intravenous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026