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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03054350 |
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Date of registration:
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13/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
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Scientific title:
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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 Dialysis-Dependent Chronic Kidney Disease (DD-CKD) |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03054350 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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Akebia Therapeutics |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sponsor GmbH |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and female Japanese subjects =20 years of age
- Receiving chronic maintenance hemodialysis for end-stage kidney disease
- Hb <10.0 g/dL
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
- Anticipated to recover adequate kidney function to no longer require hemodialysis
during study participation
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dialysis Dependent Chronic Kidney Disease
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Anemia
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Intervention(s)
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Drug: Placebo
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Drug: Vadadustat
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Primary Outcome(s)
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Mean change in Hb levels from pre-treatment to the end of the primary efficacy period
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Mean change in Hb between pre-treatment and the end of the dose adjustment and maintenance period
[Time Frame: 16 weeks]
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Time to reach target Hb level from baseline
[Time Frame: 16 weeks]
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Adverse Events (AEs) and Serious Adverse Events (SAEs)
[Time Frame: 16 weeks]
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Need for red blood cell transfusion or rescue with an erythropoiesis-stimulating agent
[Time Frame: 16 weeks]
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Secondary ID(s)
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AKB-6548-CI-0022
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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