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

Sponsor

Akebia Therapeutics (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03242967

Collaborator

(none)

Enrollment

Location

Arms

6.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Anemia Dialysis-Dependent Chronic Kidney Disease	Drug: Vadadustat Drug: Darbepoetin alfa	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Anticipated Study Start Date :

Aug 1, 2017

Actual Primary Completion Date :

Feb 12, 2018

Actual Study Completion Date :

Feb 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vadadustat Oral tablet	Drug: Vadadustat Oral tablet Other Names: AKB-6548
Active Comparator: Darbepoetin alfa subcutaneous or intravenous	Drug: Darbepoetin alfa subcutaneous or intravenous Other Names: Aranesp

Arm

Intervention/Treatment

Experimental: Vadadustat

Oral tablet

Drug: Vadadustat

Oral tablet

Other Names:

AKB-6548

Active Comparator: Darbepoetin alfa

subcutaneous or intravenous

Drug: Darbepoetin alfa

subcutaneous or intravenous

Other Names:

Aranesp

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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