NCT03054350

Brief Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Dialysis-dependent Chronic Kidney Disease (DD-CKD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

18 active sites

Status
completed

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

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2018

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

February 13, 2017

Results QC Date

February 2, 2021

Last Update Submit

March 15, 2021

Conditions

AnemiaDialysis Dependent Chronic Kidney Disease

Keywords

Anemiakidneydialysis dependent chronic kidney diseaseCKDDDrenalvadadustatAKB-6548hypoxia-inducible factorAkebia (AKB)hypoxia-inducible factor (HIF)HIFprolyl-hydroxylase inhibitor (PHI)PHIJapanJapanese

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period

    The pre-treatment average value for Hb was defined as the average of 3 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 6 value minus the Pre-treatment value.

    Pre-treatment; Week 6

Secondary Outcomes (23)

  • Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16

    from Baseline up to Week 16

  • Mean Hb Levels at the End of the Primary Efficacy Period

    up to Week 6

  • Mean Hb Levels at the End of the Dose Adjustment and Maintenance Period

    up to Week 16

  • Number of Participants Who Achieved the Target Hb Level of 10.0 to 12.0 g/dL at the End of the Dose Adjustment and Maintenance Period

    up to Week 16

  • Mean Change in Hb Between Pre-treatment and the End of the Dose Adjustment and Maintenance Period

    Pre-treatment; Week 16

  • +18 more secondary outcomes

Study Arms (4)

Vadadustat, Dose 1

EXPERIMENTAL

Daily oral dose

Drug: Vadadustat

Vadadustat, Dose 2

EXPERIMENTAL

Daily oral dose

Drug: Vadadustat

Vadadustat, Dose 3

EXPERIMENTAL

Daily oral dose

Drug: Vadadustat

Placebo

PLACEBO COMPARATOR

Daily oral dose

Drug: Placebo

Interventions

VadadustatDRUG

Daily oral dose

Also known as: AKB-6548
Vadadustat, Dose 1Vadadustat, Dose 2Vadadustat, Dose 3
PlaceboDRUG

Daily oral dose

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female Japanese participants ≥20 years of age
  • Receiving chronic maintenance hemodialysis for end-stage kidney disease
  • Hemoglobin (Hb) \<10.0 grams per deciliter (g/dL)

You may not qualify if:

  • Anemia due to a cause other than chronic kidney disease (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 (18)

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Ehime, Japan

Location

Unknown Facility

Fukui, Japan

Location

Unknown Facility

Hiroshima, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Hyōgo, Japan

Location

Unknown Facility

Ibaraki, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Kochi, Japan

Location

Unknown Facility

Miyagi, Japan

Location

Unknown Facility

Nagano, Japan

Location

Unknown Facility

Nagasaki, Japan

Location

Unknown Facility

Niigata, Japan

Location

Unknown Facility

Okinawa, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Ōita, Japan

Location

Unknown Facility

Saitama, Japan

Location

Unknown Facility

Shizuoka, Japan

Location

Related Publications (1)

  • Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

    PMID: 36005278DERIVED

MeSH Terms

Conditions

Anemia

Interventions

vadadustat

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Akebia Therapeutics
Organization
Akebia Therapeutics
trials@akebia.com
(617) 844-6128

Study Officials

  • Akebia Therapeutics

    Sponsor GmbH

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 15, 2017

Study Start

December 1, 2016

Primary Completion

October 24, 2017

Study Completion

January 24, 2018

Last Updated

April 8, 2021

Results First Posted

April 8, 2021

Record last verified: 2021-03

Locations

JP(18)