Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE February 13, 2017
First Posted Date  ICMJE February 15, 2017
Last Update Posted Date November 12, 2018
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date July 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
Mean change in Hb levels from pre-treatment to the end of the primary efficacy period [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03054337 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
  • Time to reach target Hb level from baseline [ Time Frame: 16 weeks ]
  • Mean change in Hb between pre-treatment and the end of the dose adjustment and maintenance period [ Time Frame: 16 weeks ]
  • Need for red blood cell transfusion or rescue with an erythropoiesis-stimulating agent [ Time Frame: 16 weeks ]
  • Adverse events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia
  • Non-dialysis Dependent Chronic Kidney Disease
Intervention  ICMJE
  • Drug: Vadadustat
    Other Name: AKB-6548
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Vadadustat, Dose 1
    Daily oral dose
    Intervention: Drug: Vadadustat
  • Experimental: Vadadustat, Dose 2
    Daily oral dose
    Intervention: Drug: Vadadustat
  • Experimental: Vadadustat, Dose 3
    Daily oral dose
    Intervention: Drug: Vadadustat
  • Placebo Comparator: Placebo
    Daily oral dose
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2017)
51
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2017)
48
Actual Study Completion Date  ICMJE August 28, 2017
Actual Primary Completion Date July 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03054337
Other Study ID Numbers  ICMJE AKB-6548-CI-0021
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Akebia Therapeutics
Study Sponsor  ICMJE Akebia Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Akebia Therapeutics Sponsor GmbH
PRS Account Akebia Therapeutics
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP