A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia
A Phase 3, Multicenter, Randomized, 2-Arm, Open-label Study of Intermittent Oral Dosing of ASP1517 for the Treatment of Anemia in Erythropoiesis Stimulating Agent-untreated Chronic Kidney Disease Patients Not on Dialysis
1 other identifier
interventional
100
1 country
38
Brief Summary
The objective of this study is to evaluate the efficacy and the safety when ASP1517 is intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis 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 P25-P50 for phase_3
Started Jan 2017
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2016
CompletedFirst Posted
Study publicly available on registry
November 16, 2016
CompletedStudy Start
First participant enrolled
January 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2018
CompletedOctober 31, 2024
October 1, 2024
1.6 years
November 13, 2016
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in hemoglobin (Hb) response rate
Hb response is defined as reaching target values for Hb.
Baseline and week 24
Secondary Outcomes (27)
Change from baseline in the average Hb from Week 18 to Week 24
Baseline and Weeks 18 to 24
Proportion of participants who achieve the target Hb level at the average of Week 18 to 24
Weeks 18 to 24
Rate of rise in Hb levels (g/dL/week) from week 0 at the earliest date of week 4, time to discontinuation, or time of dose adjustment
Up to Week 4
Proportion of measurement points with the target Hb level
Weeks 18 to 24
Proportion of participants who achieves the target Hb level at each week
Up to Week 24
- +22 more secondary outcomes
Study Arms (2)
ASP1517 Low dose group
EXPERIMENTALStudy drug will be dosed three times weekly for 24 weeks and dose adjustments will be made during the study.
ASP1517 High dose group
EXPERIMENTALStudy drug will be dosed three times weekly for 24 weeks and dose adjustments will be made during the study.
Interventions
Oral administration
Eligibility Criteria
You may qualify if:
- Subjects who were diagnosed with non-dialysis chronic kidney disease (CKD) and who are considered not to require renal replacement therapy during the study period
- Mean of the subject's two most recent Hb values before randomization during the Screening Period must be \<10.5 g/dL with an absolute difference ≤1.3 g/dL between the two values
- Either transferrin saturation ≥ 5% or serum ferritin ≥ 30 ng/mL
- Female subject must either:
- Be of non-childbearing potential:
- post-menopausal prior to pre-screening, or
- documented surgically sterile Or, if of childbearing potential,
- Agree not to try to become pregnant during the study after informed consent acquisition and for 28 days after the final study drug administration
- And have a negative urine pregnancy test at pre-screening
- And, if heterosexually active, agree to consistently use two forms of highly effective birth control (at least one of which must be a barrier method) starting at pre-screening and throughout the study period and for 28 days after the final study drug administration.
- Female subject must agree not to breastfeed starting at pre-screening and throughout the study period, and for 28 days after the final study drug administration.
- Female subject must not donate ova starting at pre-screening and throughout the study period, and 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 birth control (at least one of which must be a barrier method) starting at pre-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 pre-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 pre-screening assessment
- Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the pre-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 ESA, protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the pre-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 pre-screening assessment
- Previous or current malignant tumor (no recurrence for at least 5 years is eligible.)
- Having undergone red blood transfusion and/or a surgical procedure considered to promote anemia within 4 weeks before the pre-screening assessment
- Having undergone a kidney transplantation
- History of serious drug allergy including anaphylactic shock
- Having a previous history of treatment with ASP1517
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Kyntra Biocollaborator
Study Sites (38)
Site JP00029
Numakunai, Iwate, Japan
Site JP00007
Aichi, Japan
Site JP00018
Aichi, Japan
Site JP00028
Aichi, Japan
Site JP00001
Chiba, Japan
Site JP00035
Ehime, Japan
Site JP00012
Fukui, Japan
Site JP00011
Fukuoka, Japan
Site JP00031
Fukuoka, Japan
Site JP00030
Hiroshima, Japan
Site JP00034
Hiroshima, Japan
Site JP00036
Hiroshima, Japan
Site JP00005
Hokkaido, Japan
Site JP00020
Hyōgo, Japan
Site JP00015
Ibaraki, Japan
Site JP00017
Ibaraki, Japan
Site JP00021
Ibaraki, Japan
Site JP00025
Ibaraki, Japan
Site JP00037
Ibaraki, Japan
Site JP00033
Ishikawa, Japan
Site JP00006
Kanagawa, Japan
Site JP00014
Kanagawa, Japan
Site JP00038
Kanagawa, Japan
Site JP00010
Miyagi, Japan
Site JP00016
Nagano, Japan
Site JP00024
Niigata, Japan
Site JP00003
Osaka, Japan
Site JP00009
Osaka, Japan
Site JP00026
Osaka, Japan
Site JP00032
Ōita, Japan
Site JP00002
Saitama, Japan
Site JP00019
Saitama, Japan
Site JP00027
Saitama, Japan
Site JP00004
Tokyo, Japan
Site JP00013
Tokyo, Japan
Site JP00022
Tokyo, Japan
Site JP00023
Tokyo, Japan
Site JP00008
Toyama, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
November 13, 2016
First Posted
November 16, 2016
Study Start
January 11, 2017
Primary Completion
August 15, 2018
Study Completion
August 15, 2018
Last Updated
October 31, 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/.