CompletedNCT02964936Updated Oct 31, 2024

A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia

A Phase 3 interventional study of roxadustat in Chronic Kidney Disease, sponsored by Astellas Pharma Inc. Completed at 38 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.

Sponsored by Astellas Pharma Inc · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study 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.

Conditions studied

Chronic Kidney Disease

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Keywords

Anemia
Non-dialysis chronic kidney disease
Roxadustat
ASP1517

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

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Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
Participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 100 participants (actual)

Study arms

Experimental
ASP1517 Low dose group
Study drug will be dosed three times weekly for 24 weeks and dose adjustments will be made during the study.
Drug: roxadustat
Experimental
ASP1517 High dose group
Study drug will be dosed three times weekly for 24 weeks and dose adjustments will be made during the study.
Drug: roxadustat

Interventions

Drugroxadustat
Oral administration
Also known as: ASP1517

What researchers measure

Primary outcomes

Change from baseline in hemoglobin (Hb) response rate
Hb response is defined as reaching target values for Hb.
Time frame: Baseline and week 24

Secondary outcomes

Change from baseline in the average Hb from Week 18 to Week 24
Time frame: Baseline and Weeks 18 to 24
Proportion of participants who achieve the target Hb level at the average of Week 18 to 24
Hb response defined as average Hb within the target range in this outcome
Time frame: 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
Time frame: Up to Week 4
Proportion of measurement points with the target Hb level
Time frame: Weeks 18 to 24
Proportion of participants who achieves the target Hb level at each week
Time frame: Up to Week 24
Proportion of participants who achieves the lower limit of the target Hb level
Time frame: Up to Week 24
Time to achieve the lower limit of the target Hb level
Time frame: Up to Week 24
Change from baseline in Hb level to each week
Time frame: Baseline and Up to Week 24
Quality of life assessed by EQ-5D-5L
EQ-5D: EuroQol 5 Dimension 5 Levels
Time frame: Up to Week 24
Quality of life assessed by FACT-An
FACT-An: Functional Assessment of Cancer Therapy-Anemia
Time frame: Up to Week 24
Number of participants with abnormal Vital signs and/or adverse events related to treatment
Time frame: Up to Week 24
Safety assessed by body weight
Time frame: Up to Week 24
Safety assessed by incidence of adverse events
Time frame: Up to Week 24
Safety assessed by standard 12-lead electrocardiogram
Time frame: Up to Week 24
Number of participants with abnormal Laboratory values and/or adverse events related to treatment
Time frame: Up to Week 24
Plasma concentration of unchanged ASP1517
Time frame: Up to Week 24
Average hematocrit level
Time frame: Up to Week 24
Average reticulocyte level
Time frame: Up to Week 24
Average iron (Fe) level
Time frame: Up to Week 24
Average ferritin level
Time frame: Up to Week 24
Average transferrin level
Time frame: Up to Week 24
Average total iron binding capacity level
Time frame: Up to Week 24
Average soluble transferrin receptor level
Time frame: Up to Week 24
Average transferrin saturation level
Time frame: Up to Week 24
Average reticulocyte hemoglobin content level
Time frame: Up to Week 24
Number of hospitalizations
Time frame: Up to Week 24
Duration of hospitalizations
Time frame: Up to Week 24

Study locations

38 sites

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
Hyogo, 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 JP00029
Iwate, 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 JP00032
Oita, Japan
Site JP00003
Osaka, Japan
Site JP00009
Osaka, Japan
Site JP00026
Osaka, 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

References and documents

Individual participant data

Plan to share: Yes — 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/.

Supporting information: Study protocol, Sap, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02964936
Lead sponsor: Astellas Pharma Inc
Collaborators: FibroGen
Responsible party: Sponsor
First posted: Nov 16, 2016
Start date: Jan 11, 2017
Primary completion: Aug 15, 2018
Completion: Aug 15, 2018
Last update: Oct 31, 2024

Study contacts

Medical Director

study director · Astellas Pharma Inc

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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