NCT03242967

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)

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2018

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

August 4, 2017

Last Update Submit

November 1, 2018

Conditions

AnemiaDialysis-Dependent Chronic Kidney Disease

Keywords

Anemiahemoglobindarbepoetin alfaTIWhypoxia-inducible factor prolyl-hydroxylase inhibitorHIF-PHIAKB-6548vadadustatrenalhypoxia-inducible factorHIFdialysis-dependent chronic kidney diseaseCKDDD-CKDkidneyerythropoiesis stimulating agentESA

Outcome Measures

Primary Outcomes (1)

  • Mean change in Hb between baseline and the primary evaluation period

    Mean change in hemoglobin will be evaluated

    Baseline visit, Week 36

Secondary Outcomes (3)

  • Mean change in Hb between baseline and the secondary evaluation period

    Baseline visit, Week 52

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

    Baseline visit, Week 36

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

    52 weeks

Study Arms (2)

Vadadustat

EXPERIMENTAL

Oral tablet

Drug: Vadadustat

Darbepoetin alfa

ACTIVE COMPARATOR

subcutaneous or intravenous

Drug: Darbepoetin alfa

Interventions

VadadustatDRUG

Oral tablet

Also known as: AKB-6548
Vadadustat
Darbepoetin alfaDRUG

subcutaneous or intravenous

Also known as: Aranesp
Darbepoetin alfa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Northridge, California, 91324, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

vadadustatDarbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Akebia Therapeutics

    Sponsor GmbH

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 8, 2017

Study Start

August 1, 2017

Primary Completion

February 12, 2018

Study Completion

February 12, 2018

Last Updated

November 5, 2018

Record last verified: 2018-11

Locations

US(1)