A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia
NCT ID: NCT02952092
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
303 participants
INTERVENTIONAL
2016-11-30
2018-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ASP1517 Group
Subjects will take the study drug at two- or three-day intervals.
roxadustat
Oral
Darbepoetin alfa Group
Subjects will take the study drug once a week.
Darbepoetin alfa
Intravenous
Interventions
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roxadustat
Oral
Darbepoetin alfa
Intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mean of the subject's two most recent Hb values before dialysis after the longest dialysis interval during the Screening Period must be ≥10.0 g/dL and ≤12.0 g/dL
* Either transferrin saturation (TSAT) ≥ 20% or serum ferritin ≥ 100 ng/mL during the screening period
* Female subject must either:
Be of non-childbearing potential:
* post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
* documented surgically sterile Or, if of childbearing potential,
* Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
* And have a negative pregnancy test at Screening
* And, if heterosexually active, agree to consistently use two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and continued for 28 days after the final study drug administration.
* Female subject must agree not to breastfeed starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
* Female subject must not donate ova starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
* Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 12 weeks after the final study drug administration
* Male subject must not donate sperm starting at Screening and throughout the study period and, for 12 weeks after the final study drug administration
Exclusion Criteria
* Concurrent autoimmune disease with inflammation that could impact erythropoiesis
* History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent gastroparesis
* Uncontrolled hypertension
* Concurrent congestive heart failure (NYHA Class III or higher)
* History of hospitalization for treatment of stroke, myocardial infarction, or pulmonary embolism within 12 weeks before the screening assessment
* Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the screening assessment, or positive for human immunodeficiency virus (HIV) in a past test
* Concurrent other form of anemia than renal anemia
* History of pure red cell aplasia
* Having received treatment with protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the screening assessment
* Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), or total bilirubin that is greater than the criteria, or previous or concurrent another serious liver disease at screening assessment
* Previous or current malignant tumor (no recurrence for at least 5 years is eligible.)
* Having undergone blood transfusion and/or a surgical procedure considered to promote anemia (excluding shunt reconstruction surgery for access to the blood) and/or ophthalmological surgery within 4 weeks before the screening assessment
* Having undergone a kidney transplantation
* Having a previous history of treatment with ASP1517
* History of serious drug allergy including anaphylactic shock
* Participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition
20 Years
ALL
No
Sponsors
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FibroGen
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Inc
Locations
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Site JP00008
Aichi, , Japan
Site JP00018
Aichi, , Japan
Site JP00020
Aichi, , Japan
Site JP00032
Aichi, , Japan
Site JP00033
Aichi, , Japan
Site JP00040
Aichi, , Japan
Site JP00004
Ehime, , Japan
Site JP00055
Ehime, , Japan
Site JP00009
Fukui, , Japan
Site JP00059
Fukui, , Japan
Site JP00014
Fukuoka, , Japan
Site JP00049
Fukuoka, , Japan
Site JP00010
Fukushima, , Japan
Site JP00056
Fukushima, , Japan
Site JP00057
Fukushima, , Japan
Site JP00030
Gifu, , Japan
Site JP00050
Gifu, , Japan
Site JP00011
Gunma, , Japan
Site JP00026
Gunma, , Japan
Site JP00037
Gunma, , Japan
Site JP00003
Hokkaido, , Japan
Site JP00031
Hokkaido, , Japan
Site JP00038
Hokkaido, , Japan
Site JP00048
Hokkaido, , Japan
Site JP00017
Ibaraki, , Japan
Site JP00041
Ibaraki, , Japan
Site JP00042
Ibaraki, , Japan
Site JP00045
Ibaraki, , Japan
Site JP00046
Ibaraki, , Japan
Site JP00047
Ibaraki, , Japan
Site JP00054
Ibaraki, , Japan
Site JP00058
Ibaraki, , Japan
Site JP00043
Kagoshima, , Japan
Site JP00005
Kanagawa, , Japan
Site JP00028
Kumamoto, , Japan
Site JP00029
Kumamoto, , Japan
Site JP00006
Kyoto, , Japan
Site JP00002
Nagano, , Japan
Site JP00012
Nagano, , Japan
Site JP00027
Nagano, , Japan
Site JP00051
Nagano, , Japan
Site JP00013
Nagasaki, , Japan
Site JP00001
Niigata, , Japan
Site JP00034
Niigata, , Japan
Site JP00036
Okayama, , Japan
Site JP00007
Osaka, , Japan
Site JP00015
Osaka, , Japan
Site JP00016
Saitama, , Japan
Site JP00035
Saitama, , Japan
Site JP00044
Tokushima, , Japan
Site JP00052
Tokyo, , Japan
Site JP00053
Tokyo, , Japan
Site JP00021
Toyama, , Japan
Site JP00022
Toyama, , Japan
Site JP00039
Toyama, , Japan
Site JP00024
Yamagata, , Japan
Site JP00025
Yamaguchi, , Japan
Countries
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References
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Hamano T, Yamaguchi Y, Goto K, Mizokawa S, Ito Y, Dellanna F, Barratt J, Akizawa T. Risk Factors for Thromboembolic Events in Patients With Dialysis-Dependent CKD: Pooled Analysis of Phase 3 Roxadustat Trials in Japan. Adv Ther. 2024 Apr;41(4):1526-1552. doi: 10.1007/s12325-023-02727-3. Epub 2024 Feb 16.
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Akizawa T, Iwasaki M, Yamaguchi Y, Majikawa Y, Reusch M. Phase 3, Randomized, Double-Blind, Active-Comparator (Darbepoetin Alfa) Study of Oral Roxadustat in CKD Patients with Anemia on Hemodialysis in Japan. J Am Soc Nephrol. 2020 Jul;31(7):1628-1639. doi: 10.1681/ASN.2019060623. Epub 2020 Jun 3.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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1517-CL-0307
Identifier Type: -
Identifier Source: org_study_id
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