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Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents

Primary Purpose

Anemia, Dialysis-Dependent Chronic Kidney Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
vadadustat
epoetin alfa
Sponsored by
Akebia Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring anemia, kidney, dialysis-dependent chronic kidney disease, CKD, DD-CKD, renal, vadadustat, AKB-6548, hypoxia-inducible factor, HIF, hypoxia-inducible factor prolyl-hydroxylase inhibitor, HIF-PHI, hyporesponder, hyporesponsive, epoetin alfa, hemoglobin, 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 hemodialysis for end-stage kidney disease
  • Currently receiving epoetin alfa for anemia
  • Hb between 8.5 and 10.0 g/dL during screening

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
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

vadadustat

epoetin alfa

Arm Description

Vadadustat daily oral dose, adjustable based on Hb level

Epoetin alfa, dose adjustable based on Hb level, as clinically indicated throughout the study

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period

Secondary Outcome Measures

Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period
Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period
Number of Participants Receiving Epoetin Alfa Rescue
Number of Participants Receiving Red Blood Cell Transfusion
Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor
Mean Weekly Dose of Intravenous Elemental Iron Administered
Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%)
Number of Participants Utilizing Resources
Number of Participants With Treatment-emergent Adverse Events
Treatment-emergent adverse events were collected in all participants enrolled in the study.

Full Information

First Posted
May 3, 2017
Last Updated
February 2, 2021
Sponsor
Akebia Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03140722
Brief Title
Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
Official Title
Phase 2, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Revised study design.
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
March 21, 2018 (Actual)
Study Completion Date
March 21, 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
No

5. Study Description

Brief Summary
This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa for the treatment of anemia in subjects with Dialysis-dependent Chronic Kidney Disease (DD-CKD) who are hyporesponsive to erythropoiesis stimulating agents (ESAs.)

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vadadustat
Arm Type
Experimental
Arm Description
Vadadustat daily oral dose, adjustable based on Hb level
Arm Title
epoetin alfa
Arm Type
Active Comparator
Arm Description
Epoetin alfa, dose adjustable based on Hb level, as clinically indicated throughout the study
Intervention Type
Drug
Intervention Name(s)
vadadustat
Other Intervention Name(s)
AKB-6548
Intervention Description
vadadustat
Intervention Type
Drug
Intervention Name(s)
epoetin alfa
Intervention Description
epoetin alfa
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period
Time Frame
Baseline; up to 20 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period
Time Frame
Baseline; up to 20 weeks
Title
Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period
Time Frame
Baseline; up to 20 weeks
Title
Number of Participants Receiving Epoetin Alfa Rescue
Time Frame
up to 20 weeks
Title
Number of Participants Receiving Red Blood Cell Transfusion
Time Frame
up to 20 weeks
Title
Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor
Time Frame
up to 20 weeks
Title
Mean Weekly Dose of Intravenous Elemental Iron Administered
Time Frame
up to 20 weeks
Title
Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%)
Time Frame
up to 20 weeks
Title
Number of Participants Utilizing Resources
Time Frame
up to 20 weeks
Title
Number of Participants With Treatment-emergent Adverse Events
Description
Treatment-emergent adverse events were collected in all participants enrolled in the study.
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects ≥18 years of age Receiving chronic maintenance hemodialysis for end-stage kidney disease Currently receiving epoetin alfa for anemia Hb between 8.5 and 10.0 g/dL during screening 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
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Research Site
City
Elk Grove
State/Province
California
ZIP/Postal Code
95758
Country
United States
Facility Name
Research Site
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Research Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Research Site
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92115
Country
United States
Facility Name
Research Site
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Research Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Research Site
City
Statesboro
State/Province
Georgia
ZIP/Postal Code
30458
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48224
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10473
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Research Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79915
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Research Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23605
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents

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