AzTrials
AzTrials

Chronic Kidney DiseasePhase 3NCT02988973

A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With Anemia

A Phase 3 study testing roxadustat and DA in people with Chronic Kidney Disease, run by Astellas Pharma Inc at 66 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 efficacy and safety of ASP1517 when converted from recombinant human erythropoietin (rHuEPO) or darbepoetin alfa (DA), compared to DA in the treatment of anemia in non-dialysis chronic kidney disease patients. 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 and DA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
66 sitesJapan
Study dates
12 Jan 2017to 26 Mar 2020
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 and who are considered not to require renal replacement therapy during the study period
  • Subjects with renal anemia who have been receiving erythropoiesis stimulating agent (ESA) by subcutaneous injection and whose Hb values are considered stable.
  • Mean of the subject's two most recent Hb values before randomization during the Screening Period must be ≥10.0 g/dL and ≤12.0 g/dL
  • Either transferrin saturation ≥ 20% or serum ferritin ≥ 100 ng/mL
  • Female subject must either:
  • Be of non-childbearing potential:
Show all 15Show fewer
  • post-menopausal, 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 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 continued 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 continued 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 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 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 untreated or macular edema untreated, and patients with any condition that significantly compromises the ability to visualize the retina
  • 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 pre-screening assessment
Show all 17Show fewer
  • 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
  • History of pure red cell aplasia
  • Having received treatment with 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 consider to promote anemia and/or ophthalmological surgery 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 or participation in this study
  • 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

66 sites in 1 country.

66 sites in 1 country

Japan66 sites

  • Site JP00049

    Aasahikawa, Hokkaido

  • Site JP00025

    Adachi-ku, Tokyo

  • Site JP00029

    Ageo, Saitama

  • Site JP00022

    Amagasaki, Hyōgo

  • Site JP00043

    Bunkyo-ku, Tokyo

  • Site JP00063

    Chiyoda-ku, Tokyo

  • Site JP00047

    Fujisawa, Kanagawa

  • Site JP00014

    Fukui

  • Site JP00033

    Fukuoka

  • Site JP00065

    Fukuoka

  • Site JP00037

    Hatsukaichi, Hiroshima

  • Site JP00059

    Higashiosaka, Osaka

  • Site JP00067

    Hino, Tokyo

  • Site JP00032

    Hiroshima

  • Site JP00039

    Hiroshima

  • Site JP00052

    Hitachi, Ibaraki

  • Site JP00005

    Izumisano, Osaka

  • Site JP00001

    Kamakura, Kanagawa

  • Site JP00035

    Kanazawa, Ishikawa-ken

  • Site JP00017

    Kasama, Ibaraki

  • Site JP00009

    Kasugai, Aichi-ken

  • Site JP00008

    Kitakyushu, Fukuoka

  • Site JP00013

    Kitakyushu, Fukuoka

  • Site JP00040

    Kitakyushu, Fukuoka

  • Site JP00057

    Kitakyushu, Fukuoka

  • Site JP00028

    Koga, Ibaraki

  • Site JP00004

    Koshigaya, Saitama

  • Site JP00020

    Koshigaya, Saitama

  • Site JP00015

    Koto-ku, Tokyo

  • Site JP00050

    Kure, Hiroshima

  • Site JP00042

    Kurume, Fukuoka

  • Site JP00045

    Kyoto

  • Site JP00002

    Maebashi, Gunma

  • Site JP00038

    Matsuyama, Ehime

  • Site JP00044

    Matsuyama, Ehime

  • Site JP00024

    Minato-ku, Tokyo

  • Site JP00031

    Morioka, Iwate

  • Site JP00006

    Musashino, Tokyo

  • Site JP00018

    Nagano

  • Site JP00068

    Nagano

  • Site JP00030

    Nagoya, Aichi-ken

  • Site JP00051

    Nagoya, Aichi-ken

  • Site JP00053

    Naka, Ibaraki

  • Site JP00026

    Niigata

  • Site JP00066

    Nishinomiya, Hyōgo

  • Site JP00034

    Ōita

  • Site JP00055

    Okayama

  • Site JP00056

    Osaka

  • Site JP00061

    Osaka

  • Site JP00060

    Ōta-ku, Tokyo

  • Site JP00011

    Sakai, Osaka

  • Site JP00003

    Sakura, Chiba

  • Site JP00007

    Sapporo, Hokkaido

  • Site JP00064

    Sapporo, Hokkaido

  • Site JP00023

    Sashima-gun, Ibaraki

  • Site JP00012

    Sendai, Miyagi

  • Site JP00062

    Tachikawa, Tokyo

  • Site JP00041

    Tajimi, Gifu

  • Site JP00019

    Toride, Ibaraki

  • Site JP00010

    Toyama

  • Site JP00021

    Toyohashi, Aichi-ken

  • Site JP00046

    Tsuchiura, Ibaraki

  • Site JP00036

    Ueda, Nagano

  • Site JP00069

    Yao, Osaka

  • Site JP00016

    Yokohama, Kanagawa

  • Site JP00048

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Phase 3 Multi-center, Randomized, Open-label, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Non-dialysis Chronic Kidney Disease Patients With Anemia

The objective of this study is to evaluate the efficacy and safety of ASP1517 when converted from recombinant human erythropoietin (rHuEPO) or darbepoetin alfa (DA), compared to DA in the treatment of anemia in non-dialysis chronic kidney disease patients. Another uncontrolled cohort will be included to evaluate the efficacy and safety of ASP1517 in patients converted from epoetin beta pegol (CERA). This study will also assess the safety/efficacy of long term treatment of ASP1517 (52 weeks).

Read the detailed description

This study consists of the following three cohorts. Cohort 1; subjects converted from rHuEPO or DA to ASP1517, Cohort 2; subjects converted from rHuEPO or DA to DA, Cohort 3; subjects converted from epoetin beta pegol (CERA) to ASP1517. In Cohort 1 and 3, ASP1517 will be administered orally for 52 weeks. In Cohort 2, DA will be administered subcutaneously for 24 weeks.

Being tested
roxadustat, DA
Keywords
Roxadustat, Anemia, Non-dialysis chronic kidney disease, 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

  • DADrug

    Subcutaneous administration

Study groups in NCT02988973
Study groupRoleWhat they receive
rHuEPO or DA to ASP1517ExperimentalParticipants will receive roxadustat according to the prior randomization treatment, with starting doses of 70mg thrice weekly (TIW) to participants on <4500 IU/week of rHuEPO or <20 microgram (μg)/week of darbepoetin alfa (DA) and 100mg TIW to participants on ≥4500 IU/week rHuEPO or ≥ 20 μg/week DA. Participants roxadustat dosage will be adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps will be as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300 mg.
Receives: Drug: roxadustat
rHuEPO or DA to DAExperimentalParticipants will receive DA according to the prior randomization treatment, with starting doses of 15 μg/2weeks to participants on ≤ 1500 IU/week of rHuEPO or <11.25 microgram (μg)/week of DA, 30μg/2weeks to participants on >1500 to <6000 IU/week of rHuEPO or ≥ 11.25 to < 22.5 μg/week of DA, 60μg/2weeks to participants on ≥ 6000 IU/week of rHuEPO or ≥ 22.5 to < 37.5 μg/week of DA, 90μg/2weeks to participants on ≥ 37.5 to < 52.5 μg/week of DA, 120μg/2weeks to participants on ≥ 52.5 to < 75 μg/week of DA, 180μg/2weeks to participants on ≥ 75 μg/week of DA. Participant's roxadustat dosage will be adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps will be as follows: 15, 30, 60, 90, 120, and 180 μg.
Receives: Drug: DA
Epoetin beta pegol to ASP1517ExperimentalParticipants will receive roxadustat according to the prior registration treatment, with starting doses of 70mg thrice weekly (TIW) to participants on ≤100 μg/week of Epoetin beta pegol and 100mg TIW to participants on >100 μg/week of Epoetin beta pegol. Participant's roxadustat dosage will be adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps will be as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300 mg.
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 the average Hemoglobin (Hb)

    Measured: Baseline and Weeks 18 to 24

Secondary outcomes (35)

  1. Average Hb from Week 18 to Week 24

    Measured: Up to Week 24

  2. Number of Participants Who Achieved the Average Hb level of 10.0 to 12.0 g/dL For Weeks 18 to 24

    Measured: Weeks 18 to 24

  3. Number of participants who achieve the target Hb level at each week

    Measured: Up to Week 24

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

    Measured: Baseline and Up to Week 52

  5. Proportion of time points that achieve the target Hb level from Weeks 18 to 24

    Measured: Up to Week 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. Quality of life assessed by SF-36

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

    Measured: Up to Week 52

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

    EQ-5D: EuroQol 5 Dimension 5 Levels

    Measured: Up to Week 52

  9. Quality of life assessed by WPAI:ANS

    WPAI:ANS: Work Productivity and Activity Impairment Questionnaire: Anaemic Symptoms

    Measured: Up to Week 52

  10. Quality of life assessed by FACT-An

    FACT-An: Functional Assessment of Cancer Therapy-Anemia

    Measured: Up to Week 52

  11. Average Hb from weeks 44 to 52

    Measured: Up to Week 52

  12. Change from baseline in the average Hb from weeks 44 to 52

    Measured: Baseline and Up to Week 52

  13. Number of Participants Who Achieved the Average Hb level of 10.0 to 12.0 g/dL For Weeks 44 to 52

    Measured: Weeks 44 to 52

  14. Number of participants who achieve the target Hb level at each week

    Measured: Up to Week 52

  15. Proportion of time points that achieve the target Hb level from Weeks 44 to 52

    Measured: Up to Week 52

  16. Average Hematocrit Level

    Measured: Up to Week 52

  17. Average Reticulocyte Level

    Measured: Up to Week 52

  18. Average Ferrum Level

    Measured: Up to Week 52

  19. Average Ferritin Level

    Measured: Up to Week 52

  20. Average Transferrin Level

    Measured: Up to Week 52

  21. Average Total Iron Binding Capacity Level

    Measured: Up to Week 52

  22. Average Soluble Transferrin Receptor Level

    Measured: Up to Week 52

  23. Average Soluble Transferrin Level

    Measured: Up to Week 52

  24. Average Reticulocyte Hemoglobin Content Level

    Measured: Up to Week 52

  25. Number of Occurence of Hospitalizations

    Measured: Up to Week 52

  26. Duration of Hospitalization

    Measured: Up to week 52

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

    Measured: Up to Week 52

  28. Safety assessed by body weight

    Measured: Up to Week 52

  29. Safety assessed by incidence of adverse events

    Measured: Up to Week 52

  30. Safety assessed by standard 12-lead electrocardiogram

    Measured: Up to Week 52

  31. Safety assessed by ophthalmological examination: Fundoscopy

    Measured: Up to Week 24

  32. Safety assessed by ophthalmological examination: optical coherence tomography

    Measured: Up to Week 24

  33. Safety assessed by ophthalmological examination: visual acuity

    Measured: Up to Week 24

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

    Measured: Up to Week 52

  35. Plasma concentration of unchanged ASP1517

    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 posted12 Dec 2016 (estimated)
  2. Study start12 Jan 2017
  3. Primary completion13 Sep 2019
  4. Study completion26 Mar 2020

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
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02988973
Sponsor's protocol ID
1517-CL-0310
Status last verified
Oct 2024
First submitted
8 Dec 2016
Last updated
31 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

  • 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, Tanaka-Amino K, Otsuka T, Yamaguchi Y. Factors Affecting Doses of Roxadustat Versus Darbepoetin Alfa for Anemia in Nondialysis Patients. Am J Nephrol. 2021;52(9):702-713. doi: 10.1159/000519043. Epub 2021 Oct 8.

    PubMed 34628408

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing roxadustat and DA in people with Chronic Kidney Disease, run by Astellas Pharma Inc at 66 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 15 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 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 66 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 NCT02988973, which also lists 2 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 31 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