Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)
Launched by AKEBIA THERAPEUTICS · Feb 13, 2017
Trial Information
Current as of May 22, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- 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
About Akebia Therapeutics
Akebia Therapeutics is a biopharmaceutical company dedicated to advancing innovative therapies for patients with kidney disease and other serious conditions. With a strong focus on developing novel treatments that enhance the management of anemia associated with chronic kidney disease, Akebia leverages its proprietary drug development platform to address unmet medical needs. Committed to scientific excellence and patient-centric solutions, the company collaborates with healthcare professionals and researchers to bring transformative therapies to market, ultimately improving the quality of life for patients and their families.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hiroshima, , Japan
Nara, , Japan
Oita, , Japan
Chiba, , Japan
Hokkaido, , Japan
Osaka, , Japan
Aichi, , Japan
Gunma, , Japan
Ibaraki, , Japan
Kanagawa, , Japan
Okinawa, , Japan
Shiga, , Japan
Okayama, , Japan
Niigata, , Japan
Hyogo, , Japan
Ehime, , Japan
Nagano, , Japan
Tokushima, , Japan
Patients applied
Trial Officials
Akebia Therapeutics
Study Director
Sponsor GmbH
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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