AzTrials
AzTrials

Hemodialysis Chronic Kidney Disease Patients With AnemiaPhase 3NCT02952092

A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia

A Phase 3 study testing roxadustat and Darbepoetin alfa in people with Hemodialysis Chronic Kidney Disease Patients With Anemia, run by Astellas Pharma Inc at 57 sites in Japan.

Completed

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
roxadustat and Darbepoetin alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
303 participants
Where
57 sitesJapan
Study dates
30 Nov 2016to 15 Mar 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 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

Japan57 sites

  • Site JP00008

    Aichi

  • Site JP00018

    Aichi

  • Site JP00020

    Aichi

  • Site JP00032

    Aichi

  • Site JP00033

    Aichi

  • Site JP00040

    Aichi

  • Site JP00004

    Ehime

  • Site JP00055

    Ehime

  • Site JP00009

    Fukui

  • Site JP00059

    Fukui

  • Site JP00014

    Fukuoka

  • Site JP00049

    Fukuoka

  • Site JP00010

    Fukushima

  • Site JP00056

    Fukushima

  • Site JP00057

    Fukushima

  • Site JP00030

    Gifu

  • Site JP00050

    Gifu

  • Site JP00011

    Gunma

  • Site JP00026

    Gunma

  • Site JP00037

    Gunma

  • Site JP00003

    Hokkaido

  • Site JP00031

    Hokkaido

  • Site JP00038

    Hokkaido

  • Site JP00048

    Hokkaido

  • Site JP00017

    Ibaraki

  • Site JP00041

    Ibaraki

  • Site JP00042

    Ibaraki

  • Site JP00045

    Ibaraki

  • Site JP00046

    Ibaraki

  • Site JP00047

    Ibaraki

  • Site JP00054

    Ibaraki

  • Site JP00058

    Ibaraki

  • Site JP00043

    Kagoshima

  • Site JP00005

    Kanagawa

  • Site JP00028

    Kumamoto

  • Site JP00029

    Kumamoto

  • Site JP00006

    Kyoto

  • Site JP00002

    Nagano

  • Site JP00012

    Nagano

  • Site JP00027

    Nagano

  • Site JP00051

    Nagano

  • Site JP00013

    Nagasaki

  • Site JP00001

    Niigata

  • Site JP00034

    Niigata

  • Site JP00036

    Okayama

  • Site JP00007

    Osaka

  • Site JP00015

    Osaka

  • Site JP00016

    Saitama

  • Site JP00035

    Saitama

  • Site JP00044

    Tokushima

  • Site JP00052

    Tokyo

  • Site JP00053

    Tokyo

  • Site JP00021

    Toyama

  • Site JP00022

    Toyama

  • Site JP00039

    Toyama

  • Site JP00024

    Yamagata

  • Site JP00025

    Yamaguchi

Other trials in Japan

About this study

Official title: 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.

Being tested
roxadustat, Darbepoetin alfa
Keywords
ASP1517, Renal anemia, Hemodialysis, Roxadustat

What participants receive

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

  • roxadustatDrug

    Also called ASP1517

    Oral

  • Darbepoetin alfaDrug

    Intravenous

Study groups in NCT02952092
Study groupRoleWhat they receive
ASP1517 GroupExperimentalSubjects will take the study drug at two- or three-day intervals.
Receives: Drug: roxadustat
Darbepoetin alfa GroupExperimentalSubjects will take the study drug once a week.
Receives: Drug: Darbepoetin alfa

What is being measured

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

  1. Change from baseline in the average hemoglobin (Hb)

    Measured: Baseline and Weeks 18 to 24

Secondary outcomes (28)

  1. Average Hb from Week 18 to Week 24

    Measured: Week 18 to 24

  2. Proportion of participants with the target Hb level from Week 18 to Week 24

    Measured: Week 18 to 24

  3. Proportion of participants with the target Hb level at each week

    Measured: Up to Week 24

  4. Change from week 0 in Hb levels to each week

    Measured: Up to Week 24

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

    Measured: Week 18 to 24

  6. 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

  7. Average hematocrit level

    Measured: Up to Week 24

  8. Average reticulocyte level

    Measured: Up to Week 24

  9. Average iron (Fe) level

    Measured: Up to Week 24

  10. Average ferritin level

    Measured: Up to Week 24

  11. Average transferrin level

    Measured: Up to Week 24

  12. Average total iron binding capacity level

    Measured: Up to Week 24

  13. Average soluble transferrin receptor level

    Measured: Up to Week 24

  14. Average transferrin saturation level

    Measured: Up to Week 24

  15. Average reticulocyte hemoglobin content level

    Measured: Up to Week 24

  16. Quality of life assessed by SF-36

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

    Measured: Up to Week 24

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

    EQ-5D-5L: EuroQol 5 Dimension 5-Levels

    Measured: Up to Week 24

  18. Quality of life assessed by FACT-An

    FACT-An: Functional Assessment of Cancer Therapy-Anemia

    Measured: Up to Week 24

  19. Number of hospitalizations

    Measured: Up to Week 24

  20. Duration of hospitalizations

    Measured: Up to Week 24

  21. Plasma concentration of unchanged ASP1517

    Measured: Up to Week 24

  22. Safety assessed by incidence of adverse events

    Measured: Up to Week 24

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

    Measured: Up to Week 24

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

    Measured: Up to Week 24

  25. Number of participants with abnormal 12-lead electrocardiogram (ECG) values

    Any clinically significant adverse changes on the ECG will be reported as adverse events.

    Measured: Up to Week 24

  26. Safety assessed by ophthalmological examination: fundoscopy

    Measured: Up to Week 24

  27. Safety assessed by ophthalmological examination: Optical coherence tomography

    Measured: Up to Week 24

  28. Safety assessed by ophthalmological examination: visual acuity

    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 posted2 Nov 2016 (estimated)
  2. Study start30 Nov 2016
  3. Primary completion13 Mar 2018
  4. Study completion15 Mar 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
Double blind
Who is masked
Participant, Investigator
Enrolment
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02952092
Sponsor's protocol ID
1517-CL-0307
Status last verified
Oct 2024
First submitted
31 Oct 2016
Last updated
30 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. 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

  • 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.

    PubMed 36005278

  • 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.

    PubMed 32493693

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing roxadustat and Darbepoetin alfa in people with Hemodialysis Chronic Kidney Disease Patients With Anemia, run by Astellas Pharma Inc at 57 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 17 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 30 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 57 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 the average hemoglobin (Hb) (time frame: Baseline and Weeks 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 NCT02952092, which also lists 3 linked publications.

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 30 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in