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Hemodialysis Patients With Renal AnemiaPhase 3NCT02779764

A Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoieses Stimulating Agent (ESA) Treatment

A Phase 3 study testing roxadustat in people with Hemodialysis Patients With Renal Anemia, run by Astellas Pharma Inc at 25 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 safety of ASP1517 in hemodialysis patients with renal anemia whose treatment is converted from an Erythropoieses Stimulating Agent formulation. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hemodialysis Patients With Renal Anemia
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
164 participants
Where
25 sitesJapan
Study dates
16 May 2016to 28 Nov 2017
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 with renal anemia who have been receiving ESA (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 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
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  • 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 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 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

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 gastro-paresis
  • 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
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  • 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 consider 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
  • 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

25 sites in 1 country.

25 sites in 1 country

Japan25 sites

  • Site JP00017

    Aichi

  • Site JP00005

    Fukuoka

  • Site JP00004

    Gunma

  • Site JP00006

    Gunma

  • Site JP00018

    Hokkaido

  • Site JP00019

    Hokkaido

  • Site JP00021

    Hokkaido

  • Site JP00023

    Hyōgo

  • Site JP00008

    Ibaraki

  • Site JP00020

    Ishikawa

  • Site JP00010

    Kumamoto

  • Site JP00022

    Kumamoto

  • Site JP00024

    Kumamoto

  • Site JP00016

    Kyoto

  • Site JP00002

    Nagano

  • Site JP00012

    Nagano

  • Site JP00015

    Nagano

  • Site JP00003

    Niigata

  • Site JP00025

    Osaka

  • Site JP00007

    Saitama

  • Site JP00009

    Shizuoka

  • Site JP00014

    Tokyo

  • Site JP00013

    Tottori

  • Site JP00011

    Wakayama

  • Site JP00001

    Yamaguchi

Other trials in Japan

About this study

Official title: A Phase 3, Long-term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoiesis Stimulating Agent Treatment

The objective of this study is to evaluate the efficacy and safety of ASP1517 in hemodialysis patients with renal anemia whose treatment is converted from an Erythropoieses Stimulating Agent formulation.

Being tested
roxadustat
Keywords
Hemodialysis, ASP1517, Roxadustat, Renal 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

Study groups in NCT02779764
Study groupRoleWhat they receive
ASP1517 GroupExperimentalStudy drug will be dosed three times weekly 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. Hemoglobin (Hb) Response Rate from Week 18 to Week 24

    Hb response defined as average Hb within the target range

    Measured: Week 18 to 24

Secondary outcomes (27)

  1. Hb Response Rate from Week 46 to Week 52

    Measured: Week 46 to 52

  2. Average Hb from Week 18 to Week 24

    Measured: Week 18 to Week 24

  3. Average Hb from Week 46 to Week 52

    Measured: Week 46 to Week 52

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

    Measured: Baseline and Weeks 18 to 24

  5. Change from baseline in the average Hb from Week 46 to Week 52

    Measured: Baseline and Weeks 46 to 52

  6. Proportion of participants with Hb values within the target value in each post-dosing time point

    Measured: Up to Week 52

  7. Change from baseline in Hb to each post-dosing time point

    Measured: Baseline and Up to Week 52

  8. Proportion of measurement points with target Hb level from Week 18 to Week 24

    Measured: Week 18 to Week 24

  9. Proportion of measurement points with target Hb level from Week 46 to Week 52

    Measured: Week 46 to Week 52

  10. 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

    Measured: Up to Week 4

  11. Average hematocrit level

    Measured: Up to Week 52

  12. Average reticulocyte level

    Measured: Up to Week 52

  13. Average Fe level

    Measured: Up to Week 52

  14. Average ferritin level

    Measured: Up to Week 52

  15. Average transferrin level

    Measured: Up to Week 52

  16. Average total iron binding capacity level

    Measured: Up to Week 52

  17. Average soluble transferrin receptor level

    Measured: Up to Week 52

  18. Average transferrin saturation level

    Measured: Up to Week 52

  19. Average reticulocyte hemoglobin content level

    Measured: Up to Week 52

  20. Quality of life assessed by SF-36

    SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey

    Measured: Up to Week 52

  21. Quality of life assessed by EQ-5D

    EQ-5D: EuroQol 5 Dimension

    Measured: Up to Week 52

  22. Quality of life assessed by FACT-An

    FACT-An: Functional Assessment of Cancer Therapy-Anemia

    Measured: Up to Week 52

  23. Number of hospitalizations

    Measured: Up to Week 52

  24. Safety assessed by incidence of adverse events

    Measured: Up to Week 52

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

    Vital signs: blood pressure and pulse rate

    Measured: Up to Week 52

  26. Safety assessed by standard 12-lead electrocardiogram

    Measured: Up to Week 52

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

    Measured: Up to Week 52

Timeline

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

  1. First posted20 May 2016 (estimated)
  2. Study start16 May 2016
  3. Primary completion16 May 2017
  4. Study completion28 Nov 2017

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02779764
Sponsor's protocol ID
1517-CL-0312
Status last verified
Oct 2024
First submitted
19 May 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/.

Publications

  • 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.

    PubMed 38363463

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing roxadustat in people with Hemodialysis Patients With Renal Anemia, run by Astellas Pharma Inc at 25 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 25 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?

Hemoglobin (Hb) Response Rate from Week 18 to Week 24 (time frame: Week 18 to 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 NCT02779764, which also lists 1 linked publication.

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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