Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)

NCT03054337 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AKB-6548-CI-0021
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 18

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 Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD).

Conditions

Anemia; Non-dialysis Dependent Chronic Kidney Disease

Keywords

Anemia; kidney; non-dialysis dependent chronic kidney disease; CKD; NDD-CKD; renal; vadadustat; AKB-6548; hypoxia-inducible factor; hypoxia-inducible factor (HIF); HIF; prolyl-hydroxylase inhibitor (PHI); PHI; Japan; Japanese; Akebia (AKB)

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 value for Hb was defined as the average of 2 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 (25)

• 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

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

Vadadustat DRUG

Also known as: AKB-6548

Vadadustat, Dose 1; Vadadustat, Dose 2; Vadadustat, Dose 3

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female Japanese participants ≥20 years of age
• Diagnosis of chronic kidney disease (CKD) based on an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m\^2)
• Hemoglobin (Hb) ≤10.5 grams per deciliter (g/dL)
• Not currently being treated with dialysis and not expected to start dialysis within 3 months of screening

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
• Intravenous iron within 4 weeks prior to or during screening
• Any use of erythropoiesis-stimulating agents within 6 weeks prior to or during screening

Sponsors & Collaborators

• Akebia Therapeutics: lead

Study Sites (18)

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Ehime, Japan

Location

Unknown Facility

Gunma, Japan

Location

Unknown Facility

Hiroshima, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Hyōgo, Japan

Location

Unknown Facility

Ibaraki, Japan

Location

Unknown Facility

Kanagawa, Japan

Location

Unknown Facility

Nagano, Japan

Location

Unknown Facility

Nara, Japan

Location

Unknown Facility

Niigata, Japan

Location

Unknown Facility

Okayama, Japan

Location

Unknown Facility

Okinawa, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Ōita, Japan

Location

Unknown Facility

Shiga, Japan

Location

Unknown Facility

Tokushima, 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: 36005278 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

vadadustat

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, 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: October 1, 2016
• Primary Completion: July 4, 2017
• Study Completion: August 28, 2017
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-03

Locations

JP (18)