A Study of Intermittent Oral Dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-Naive Hemodialysis Chronic Kidney Disease Patients With Anemia
A Phase 3, Multi-center, Randomized, 2-arm, Open-label Study of Intermittent Oral Dosing of ASP1517 in Erythropoiesis Stimulating Agent-naive Hemodialysis Chronic Kidney Disease Patients With Anemia
1 other identifier
interventional
75
1 country
47
Brief Summary
The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive hemodialysis chronic kidney disease patients with anemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2016
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2016
CompletedFirst Posted
Study publicly available on registry
May 23, 2016
CompletedStudy Start
First participant enrolled
June 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2017
CompletedOctober 30, 2024
October 1, 2024
1.5 years
May 19, 2016
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin (Hb) Response rate
Hb response is defined as reaching target values for Hb and change of Hb from baseline
Up to Week 24
Secondary Outcomes (27)
Average Hb level from Week 18 to 24
Week 18 to 24
Change from baseline in the average Hb level from Week 18 to 24
Baseline and Weeks 18 to 24
Proportion of participants with the target Hb level from Week 18 to 24
Week 18 to 24
Rate of rise in Hb levels (g/dL/week) from week 0 to at the earliest date of week 4, time of discontinuation, or time of dose adjustment
Up to Week 4
Proportion of measurement points with the target Hb level
Up to Week 24
- +22 more secondary outcomes
Study Arms (2)
ASP1517 Low dose Group
EXPERIMENTALStudy drug will be dosed three times weekly and dose adjustments will be made during the study.
ASP1517 High dose Group
EXPERIMENTALStudy drug will be dosed three times weekly and dose adjustments will be made during the study.
Interventions
Eligibility Criteria
You may qualify if:
- Mean of the subjects' two most recent Hb values during the Screening Period must be ≤10.0 g/dL with an absolute difference ≤1.0 g/dL between the two values
- Either transferrin saturation (TSAT) ≥ 5% or serum ferritin ≥ 30 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
You may not qualify if:
- Concurrent retinal neovascular lesion requiring treatment and macular edema requiring treatment
- 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
- 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) 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Kyntra Biocollaborator
Study Sites (47)
Site JP00003
Aichi, Japan
Site JP00005
Aichi, Japan
Site JP00042
Aichi, Japan
Site JP00044
Aichi, Japan
Site JP00020
Chiba, Japan
Site JP00010
Ehime, Japan
Site JP00021
Ehime, Japan
Site JP00013
Fukuoka, Japan
Site JP00011
Fukushima, Japan
Site JP00035
Fukushima, Japan
Site JP00017
Gifu, Japan
Site JP00033
Gifu, Japan
Site JP00012
Gunma, Japan
Site JP00016
Gunma, Japan
Site JP00025
Gunma, Japan
Site JP00046
Hiroshima, Japan
Site JP00015
Hokkaido, Japan
Site JP00023
Hokkaido, Japan
Site JP00028
Hokkaido, Japan
Site JP00038
Hokkaido, Japan
Site JP00040
Hokkaido, Japan
Site JP00045
Hokkaido, Japan
Site JP00034
Hyōgo, Japan
Site JP00008
Ibaraki, Japan
Site JP00018
Ibaraki, Japan
Site JP00027
Ibaraki, Japan
Site JP00030
Ibaraki, Japan
Site JP00022
Ishikawa, Japan
Site JP00041
Kagoshima, Japan
Site JP00031
Kumamoto, Japan
Site JP00037
Kumamoto, Japan
Site JP00009
Nagano, Japan
Site JP00014
Nagano, Japan
Site JP00026
Nagano, Japan
Site JP00047
Nagano, Japan
Site JP00002
Niigata, Japan
Site JP00029
Niigata, Japan
Site JP00039
Okayama, Japan
Site JP00024
Okinawa, Japan
Site JP00036
Osaka, Japan
Site JP00006
Saitama, Japan
Site JP00032
Shizuoka, Japan
Site JP00043
Tokushima, Japan
Site JP00048
Tokyo, Japan
Site JP00007
Tottori, Japan
Site JP00019
Toyama, Japan
Site JP00004
Yamaguchi, Japan
Related Publications (2)
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.
PMID: 38363463DERIVEDNatale 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.
PMID: 36005278DERIVED
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2016
First Posted
May 23, 2016
Study Start
June 2, 2016
Primary Completion
December 12, 2017
Study Completion
December 12, 2017
Last Updated
October 30, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.