- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02952092
A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia
September 28, 2022 updated by: Astellas Pharma Inc
A Phase 3, Multi-center, Randomized, 2-arm Parallel, Double-blind, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia
The objective of this study is to evaluate the safety and efficacy of ASP1517 compared to darbepoetin alfa in hemodialysis chronic kidney disease patients with anemia.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
303
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Aichi, Japan
- Site JP00008
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Aichi, Japan
- Site JP00018
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Aichi, Japan
- Site JP00020
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Aichi, Japan
- Site JP00032
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Aichi, Japan
- Site JP00033
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Aichi, Japan
- Site JP00040
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Ehime, Japan
- Site JP00004
-
Ehime, Japan
- Site JP00055
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Fukui, Japan
- Site JP00009
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Fukui, Japan
- Site JP00059
-
Fukuoka, Japan
- Site JP00014
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Fukuoka, Japan
- Site JP00049
-
Fukushima, Japan
- Site JP00010
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Fukushima, Japan
- Site JP00056
-
Fukushima, Japan
- Site JP00057
-
Gifu, Japan
- Site JP00030
-
Gifu, Japan
- Site JP00050
-
Gunma, Japan
- Site JP00011
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Gunma, Japan
- Site JP00026
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Gunma, Japan
- Site JP00037
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Hokkaido, Japan
- Site JP00003
-
Hokkaido, Japan
- Site JP00038
-
Hokkaido, Japan
- Site JP00031
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Hokkaido, Japan
- Site JP00048
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Ibaraki, Japan
- Site JP00017
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Ibaraki, Japan
- Site JP00041
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Ibaraki, Japan
- Site JP00042
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Ibaraki, Japan
- Site JP00045
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Ibaraki, Japan
- Site JP00046
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Ibaraki, Japan
- Site JP00047
-
Ibaraki, Japan
- Site JP00054
-
Ibaraki, Japan
- Site JP00058
-
Kagoshima, Japan
- Site JP00043
-
Kanagawa, Japan
- Site JP00005
-
Kumamoto, Japan
- Site JP00028
-
Kumamoto, Japan
- Site JP00029
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Kyoto, Japan
- Site JP00006
-
Nagano, Japan
- Site JP00027
-
Nagano, Japan
- Site JP00002
-
Nagano, Japan
- Site JP00012
-
Nagano, Japan
- Site JP00051
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Nagasaki, Japan
- Site JP00013
-
Niigata, Japan
- Site JP00001
-
Niigata, Japan
- Site JP00034
-
Okayama, Japan
- Site JP00036
-
Osaka, Japan
- Site JP00007
-
Osaka, Japan
- Site JP00015
-
Saitama, Japan
- Site JP00016
-
Saitama, Japan
- Site JP00035
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Tokushima, Japan
- Site JP00044
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Tokyo, Japan
- Site JP00052
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Tokyo, Japan
- Site JP00053
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Toyama, Japan
- Site JP00021
-
Toyama, Japan
- Site JP00022
-
Toyama, Japan
- Site JP00039
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Yamagata, Japan
- Site JP00024
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Yamaguchi, Japan
- Site JP00025
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with renal anemia who have been receiving recombinant human erythropoietin (rHuEPO, two times weekly or three times weekly) or darbepoetin alfa (intravenous treatment) within the doses approved in Japan for more than 8 weeks before the screening assessment
- 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 retinal neovascular lesion untreated and macular edema untreated
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ASP1517 Group
Subjects will take the study drug at two- or three-day intervals.
|
Oral
Other Names:
|
Experimental: Darbepoetin alfa Group
Subjects will take the study drug once a week.
|
Intravenous
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in the average hemoglobin (Hb)
Time Frame: Baseline and Weeks 18 to 24
|
Baseline and Weeks 18 to 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life assessed by SF-36
Time Frame: Up to Week 24
|
SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey
|
Up to Week 24
|
Quality of life assessed by FACT-An
Time Frame: Up to Week 24
|
FACT-An: Functional Assessment of Cancer Therapy-Anemia
|
Up to Week 24
|
Safety assessed by incidence of adverse events
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Number of participants with abnormal Vital signs and/or adverse events related to treatment
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Number of participants with abnormal Laboratory values and/or adverse events related to treatment
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Plasma concentration of unchanged ASP1517
Time Frame: Up to Week 24
|
Up to Week 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
Time Frame: Up to Week 4
|
Up to Week 4
|
|
Proportion of participants with the target Hb level at each week
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Average hematocrit level
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Average reticulocyte level
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Average iron (Fe) level
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Average ferritin level
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Average transferrin level
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Average total iron binding capacity level
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Average soluble transferrin receptor level
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Average transferrin saturation level
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Average reticulocyte hemoglobin content level
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Number of hospitalizations
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Duration of hospitalizations
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Average Hb from Week 18 to Week 24
Time Frame: Week 18 to 24
|
Week 18 to 24
|
|
Proportion of participants with the target Hb level from Week 18 to Week 24
Time Frame: Week 18 to 24
|
Week 18 to 24
|
|
Change from week 0 in Hb levels to each week
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Proportion of measurement points with the target Hb level from Week 18 to Week 24
Time Frame: Week 18 to 24
|
Week 18 to 24
|
|
Quality of life assessed by EQ-5D-5L
Time Frame: Up to Week 24
|
EQ-5D-5L: EuroQol 5 Dimension 5-Levels
|
Up to Week 24
|
Number of participants with abnormal 12-lead electrocardiogram (ECG) values
Time Frame: Up to Week 24
|
Any clinically significant adverse changes on the ECG will be reported as adverse events.
|
Up to Week 24
|
Safety assessed by ophthalmological examination: fundoscopy
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Safety assessed by ophthalmological examination: Optical coherence tomography
Time Frame: Up to Week 24
|
Up to Week 24
|
|
Safety assessed by ophthalmological examination: visual acuity
Time Frame: Up to Week 24
|
Up to Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2016
Primary Completion (Actual)
March 13, 2018
Study Completion (Actual)
March 15, 2018
Study Registration Dates
First Submitted
October 31, 2016
First Submitted That Met QC Criteria
October 31, 2016
First Posted (Estimate)
November 2, 2016
Study Record Updates
Last Update Posted (Actual)
September 30, 2022
Last Update Submitted That Met QC Criteria
September 28, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1517-CL-0307
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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