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

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)

Sponsors

Lead Sponsor: Akebia Therapeutics

Source 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.

Overall Status Completed
Start Date October 2016
Completion Date August 28, 2017
Primary Completion Date July 5, 2017
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean change in Hb levels from pre-treatment to the end of the primary efficacy period 6 weeks
Secondary Outcome
Measure Time Frame
Time to reach target Hb level from baseline 16 weeks
Mean change in Hb between pre-treatment and the end of the dose adjustment and maintenance period 16 weeks
Need for red blood cell transfusion or rescue with an erythropoiesis-stimulating agent 16 weeks
Adverse events (AEs) and Serious Adverse Events (SAEs) 16 weeks
Enrollment 51
Condition
Intervention

Intervention Type: Drug

Intervention Name: Vadadustat

Other Name: AKB-6548

Intervention Type: Drug

Intervention Name: Placebo

Arm Group Label: Placebo

Eligibility

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

Gender: All

Minimum Age: 20 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Akebia Therapeutics Study Director Sponsor GmbH
Location
Facility:
| 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
Location Countries

Japan

Verification Date

November 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Vadadustat, Dose 1

Type: Experimental

Description: Daily oral dose

Label: Vadadustat, Dose 2

Type: Experimental

Description: Daily oral dose

Label: Vadadustat, Dose 3

Type: Experimental

Description: Daily oral dose

Label: Placebo

Type: Placebo Comparator

Description: Daily oral dose

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov