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

Anemia Clinical Trial

— TRILOGY  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03242967
• Other study ID #: AKB-6548-CI-0023
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 2017
• Est. completion date: February 12, 2018

Study information

• Verified date: November 2018
• Source: Akebia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 12, 2018
• Est. primary completion date: February 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Dialysis-Dependent Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Vadadustat
Oral tablet
• Darbepoetin alfa
subcutaneous or intravenous

Locations

Country	Name	City	State
United States	Research Site	Northridge	California

Sponsors (1)

Lead Sponsor	Collaborator
Akebia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

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