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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)

Primary Purpose

Anemia, Dialysis-Dependent Chronic Kidney Disease

Status

Withdrawn

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Vadadustat

Darbepoetin alfa

About this trial

This is an interventional treatment trial for Anemia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vadadustat

Darbepoetin alfa

Arm Description

Oral tablet

subcutaneous or intravenous

Outcomes

Primary Outcome Measures

Mean change in Hb between baseline and the primary evaluation period

Mean change in hemoglobin will be evaluated

Secondary Outcome Measures

Mean change in Hb between baseline and the secondary evaluation period

Mean change in hemoglobin will be evaluated

Proportion of subjects with mean Hb within the target range during the primary evaluation period

Hemoglobin values within the target range will be evaluated

Adverse Events (AEs) and Serious Adverse Events (SAEs)

Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated

Full Information

NCT ID

NCT03242967

First Posted

August 4, 2017

Last Updated

November 1, 2018

Sponsor

Akebia Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03242967

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Revised study design.

Study Start Date

August 2017 (Anticipated)

Primary Completion Date

February 12, 2018 (Actual)

Study Completion Date

February 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Akebia Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vadadustat

Arm Type

Experimental

Arm Description

Oral tablet

Arm Title

Darbepoetin alfa

Arm Type

Active Comparator

Arm Description

subcutaneous or intravenous

Intervention Type

Drug

Intervention Name(s)

Vadadustat

Other Intervention Name(s)

AKB-6548

Intervention Description

Oral tablet

Intervention Type

Drug

Intervention Name(s)

Darbepoetin alfa

Other Intervention Name(s)

Aranesp

Intervention Description

subcutaneous or intravenous

Primary Outcome Measure Information:

Title

Mean change in Hb between baseline and the primary evaluation period

Description

Mean change in hemoglobin will be evaluated

Time Frame

Baseline visit, Week 36

Secondary Outcome Measure Information:

Title

Mean change in Hb between baseline and the secondary evaluation period

Description

Mean change in hemoglobin will be evaluated

Time Frame

Baseline visit, Week 52

Title

Proportion of subjects with mean Hb within the target range during the primary evaluation period

Description

Hemoglobin values within the target range will be evaluated

Time Frame

Baseline visit, Week 36

Title

Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Akebia Therapeutics

Organizational Affiliation

Sponsor GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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