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Chronic Kidney DiseasePhase 3NCT02964936

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

A Phase 3 study testing roxadustat in people with Chronic Kidney Disease, run by Astellas Pharma Inc at 38 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Chronic Kidney Disease
What is being tested?
roxadustat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
38 sitesJapan
Study dates
11 Jan 2017to 15 Aug 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

Japan38 sites

  • Site JP00007

    Aichi

  • Site JP00018

    Aichi

  • Site JP00028

    Aichi

  • Site JP00001

    Chiba

  • Site JP00035

    Ehime

  • Site JP00012

    Fukui

  • Site JP00011

    Fukuoka

  • Site JP00031

    Fukuoka

  • Site JP00030

    Hiroshima

  • Site JP00034

    Hiroshima

  • Site JP00036

    Hiroshima

  • Site JP00005

    Hokkaido

  • Site JP00020

    Hyōgo

  • Site JP00015

    Ibaraki

  • Site JP00017

    Ibaraki

  • Site JP00021

    Ibaraki

  • Site JP00025

    Ibaraki

  • Site JP00037

    Ibaraki

  • Site JP00033

    Ishikawa

  • Site JP00006

    Kanagawa

  • Site JP00014

    Kanagawa

  • Site JP00038

    Kanagawa

  • Site JP00010

    Miyagi

  • Site JP00016

    Nagano

  • Site JP00024

    Niigata

  • Site JP00029

    Numakunai, Iwate

  • Site JP00032

    Ōita

  • Site JP00003

    Osaka

  • Site JP00009

    Osaka

  • Site JP00026

    Osaka

  • Site JP00002

    Saitama

  • Site JP00019

    Saitama

  • Site JP00027

    Saitama

  • Site JP00004

    Tokyo

  • Site JP00013

    Tokyo

  • Site JP00022

    Tokyo

  • Site JP00023

    Tokyo

  • Site JP00008

    Toyama

Other trials in Japan

About this study

Official title: 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

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.

Being tested
roxadustat
Keywords
Anemia, Non-dialysis chronic kidney disease, Roxadustat, ASP1517
Medical subject headings
Renal Insufficiency, Chronic, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • roxadustatDrug

    Also called ASP1517

    Oral administration

Study groups in NCT02964936
Study groupRoleWhat they receive
ASP1517 Low dose groupExperimentalStudy drug will be dosed three times weekly for 24 weeks and dose adjustments will be made during the study.
Receives: Drug: roxadustat
ASP1517 High dose groupExperimentalStudy drug will be dosed three times weekly for 24 weeks and dose adjustments will be made during the study.
Receives: Drug: roxadustat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in hemoglobin (Hb) response rate

    Hb response is defined as reaching target values for Hb.

    Measured: Baseline and week 24

Secondary outcomes (27)

  1. Change from baseline in the average Hb from Week 18 to Week 24

    Measured: Baseline and Weeks 18 to 24

  2. 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

    Measured: Weeks 18 to 24

  3. 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

    Measured: Up to Week 4

  4. Proportion of measurement points with the target Hb level

    Measured: Weeks 18 to 24

  5. Proportion of participants who achieves the target Hb level at each week

    Measured: Up to Week 24

  6. Proportion of participants who achieves the lower limit of the target Hb level

    Measured: Up to Week 24

  7. Time to achieve the lower limit of the target Hb level

    Measured: Up to Week 24

  8. Change from baseline in Hb level to each week

    Measured: Baseline and Up to Week 24

  9. Quality of life assessed by EQ-5D-5L

    EQ-5D: EuroQol 5 Dimension 5 Levels

    Measured: Up to Week 24

  10. Quality of life assessed by FACT-An

    FACT-An: Functional Assessment of Cancer Therapy-Anemia

    Measured: Up to Week 24

  11. Number of participants with abnormal Vital signs and/or adverse events related to treatment

    Measured: Up to Week 24

  12. Safety assessed by body weight

    Measured: Up to Week 24

  13. Safety assessed by incidence of adverse events

    Measured: Up to Week 24

  14. Safety assessed by standard 12-lead electrocardiogram

    Measured: Up to Week 24

  15. Number of participants with abnormal Laboratory values and/or adverse events related to treatment

    Measured: Up to Week 24

  16. Plasma concentration of unchanged ASP1517

    Measured: Up to Week 24

  17. Average hematocrit level

    Measured: Up to Week 24

  18. Average reticulocyte level

    Measured: Up to Week 24

  19. Average iron (Fe) level

    Measured: Up to Week 24

  20. Average ferritin level

    Measured: Up to Week 24

  21. Average transferrin level

    Measured: Up to Week 24

  22. Average total iron binding capacity level

    Measured: Up to Week 24

  23. Average soluble transferrin receptor level

    Measured: Up to Week 24

  24. Average transferrin saturation level

    Measured: Up to Week 24

  25. Average reticulocyte hemoglobin content level

    Measured: Up to Week 24

  26. Number of hospitalizations

    Measured: Up to Week 24

  27. Duration of hospitalizations

    Measured: Up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2016 (estimated)
  2. Study start11 Jan 2017
  3. Primary completion15 Aug 2018
  4. Study completion15 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02964936
Sponsor's protocol ID
1517-CL-0314
Status last verified
Oct 2024
First submitted
13 Nov 2016
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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/.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing roxadustat in people with Chronic Kidney Disease, run by Astellas Pharma Inc at 38 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in hemoglobin (Hb) response rate (time frame: Baseline and week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02964936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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