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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03054337
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Akebia Therapeutics

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 subjects with anemia secondary to NDD-CKD.

Condition or disease Intervention/treatment Phase
Anemia Non-dialysis Dependent Chronic Kidney Disease Drug: Vadadustat Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)
Actual Study Start Date : October 2016
Actual Primary Completion Date : July 5, 2017
Actual Study Completion Date : August 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vadadustat, Dose 1
Daily oral dose
Drug: Vadadustat
Other Name: AKB-6548

Experimental: Vadadustat, Dose 2
Daily oral dose
Drug: Vadadustat
Other Name: AKB-6548

Experimental: Vadadustat, Dose 3
Daily oral dose
Drug: Vadadustat
Other Name: AKB-6548

Placebo Comparator: Placebo
Daily oral dose
Drug: Placebo



Primary Outcome Measures :
  1. Mean change in Hb levels from pre-treatment to the end of the primary efficacy period [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Time to reach target Hb level from baseline [ Time Frame: 16 weeks ]
  2. Mean change in Hb between pre-treatment and the end of the dose adjustment and maintenance period [ Time Frame: 16 weeks ]
  3. Need for red blood cell transfusion or rescue with an erythropoiesis-stimulating agent [ Time Frame: 16 weeks ]
  4. Adverse events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female Japanese subjects ≥20 years of age
  • Diagnosis of CKD based on an estimated glomerular filtration rate ≤60 mL/min/1.73 m2
  • Hb ≤10.5 g/dL
  • Not currently being treated with dialysis and not expected to start dialysis within 3 months of 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
  • Intravenous iron within 4 weeks prior to or during screening
  • Any use of erythropoiesis-stimulating agents within 6 weeks prior to or during screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054337


Locations
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Japan
Aichi, Japan
Chiba, Japan
Ehime, Japan
Gunma, Japan
Hiroshima, Japan
Hokkaido, Japan
Hyogo, Japan
Ibaraki, Japan
Kanagawa, Japan
Nagano, Japan
Nara, Japan
Niigata, Japan
Oita, Japan
Okayama, Japan
Okinawa, Japan
Osaka, Japan
Shiga, Japan
Tokushima, Japan
Sponsors and Collaborators
Akebia Therapeutics
Investigators
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Study Director: Akebia Therapeutics Sponsor GmbH

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Responsible Party: Akebia Therapeutics
ClinicalTrials.gov Identifier: NCT03054337     History of Changes
Other Study ID Numbers: AKB-6548-CI-0021
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Akebia Therapeutics:
Akebia (AKB)
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

Additional relevant MeSH terms:
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Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs