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Peritoneal Dialysis Chronic Kidney Disease Patients With AnemiaPhase 3NCT02780726

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

A Phase 3 study testing roxadustat in people with Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia, run by Astellas Pharma Inc at 15 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 safety and efficacy of ASP1517 in peritoneal dialysis 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
15 sitesJapan
Study dates
22 Jun 2016to 2 Aug 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

  • Female subject must either:
  • Be of non-childbearing potential:
  • post-menopausal (defined as at least 1 year without any menses) prior to Screening, 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 pregnancy test at Screening
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  • 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
  • Subjects who have not received Erythropoieses Stimulating Agents (ESAs):
  • Subjects who have been receiving peritoneal dialysis for more than 4 weeks before the screening assessment
  • Subjects who have never received ESAs after starting peritoneal dialysis, or subjects who have not received ESAs within 6 weeks before the screening assessment.
  • 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 (TSAT) ≥ 5% or serum ferritin ≥ 30 ng/mL during the screening period
  • Subjects who have been receiving ESAs:
  • Subjects with renal anemia who have been receiving ESA within the doses approved in Japan for more than 8 weeks after starting peritoneal dialysis, before the screening assessment
  • 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
  • TSAT ≥ 20% or serum ferritin ≥ 100 ng/mL during the screening period

Who cannot join

  • Subjects who had trouble with continuing peritoneal dialysis due to peritonitis, development of catheter trouble (e.g. tunnel infection) within 4 weeks before the screening assessment
  • 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)
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  • History of hospitalization for treatment of stroke, myocardial infarction, or pulmonary embolism within 12 weeks before the screening assessment
  • 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), total bilirubin, or Alkaline Phosphatase (ALP) that is greater than the criteria below, 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) 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

15 sites in 1 country.

15 sites in 1 country

Japan15 sites

  • Site JP00002

    Aichi

  • Site JP00004

    Aichi

  • Site JP00010

    Aichi

  • Site JP00013

    Aichi

  • Site JP00001

    Fukuoka

  • Site JP00005

    Fukuoka

  • Site JP00012

    Hokkaido

  • Site JP00014

    Hokkaido

  • Site JP00006

    Ishikawa

  • Site JP00008

    Kanagawa

  • Site JP00003

    Nagano

  • SIte JP00015

    Okayama

  • Site JP00009

    Osaka

  • Site JP00007

    Tokushima

  • Site JP00011

    Toyama

Other trials in Japan

About this study

Official title: A Phase 3, Multi-center, Open-label Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia

The objective of this study is to evaluate the safety and efficacy of ASP1517 in peritoneal dialysis chronic kidney disease patients with anemia.

Being tested
roxadustat
Keywords
Peritoneal dialysis, Roxadustat, Renal anemia, ASP1517

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 NCT02780726
Study groupRoleWhat they receive
ASP1517 Low Dose Group (ESA Untreated)ExperimentalThis group includes subjects who have not received Erythropoieses Stimulating Agents (ESAs). Study drug will be dosed three times weekly and dose adjustments will be made during the study.
Receives: Drug: roxadustat
ASP1517 High Dose Group (ESA Untreated)ExperimentalThis group includes subjects who have not received ESAs. Study drug will be dosed three times weekly and dose adjustments will be made during the study.
Receives: Drug: roxadustat
ASP1517 ESAs Treated GroupExperimentalThis group includes subjects who have received ESAs. The treatment was converted from ESAs to study drug. Study 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 in this outcome

    Measured: Up to Week 24

Secondary outcomes (27)

  1. Hb Response rate

    Hb response is defined as reaching target values for Hb and change of Hb from baseline in this outcome.

    Measured: Up to Week 24

  2. Average Hb levels from week 18 to week 24

    Measured: Up to week 24

  3. Change from baseline in the average Hb levels of week 18 to week 24

    Measured: Baseline and up to Week 24

  4. Rate of rise in Hb levels (g/dL/week)

    Measured: Up to Week 4

  5. Proportion of time points with target Hb levels

    Measured: Up to Week 24

  6. Proportion of participants who achieve the target Hb level at each week

    Measured: Up to Week 24

  7. Proportion of participants who achieve the lower limit of the target Hb level

    Measured: Up to Week 24

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

    Measured: Up to Week 24

  9. Change from baseline in Hb level at each week

    Measured: Baseline and Up to Week 24

  10. Efficacy assessed by hematocrit

    Hematocrit will be summarized by ASP1517 low dose Erythropoieses Stimulating Agent (ESA) untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.

    Measured: Up to Week 24

  11. Efficacy assessed by reticulocytes/ erythrocytes

    Reticulocytes/Erythrocytes will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.

    Measured: Up to Week 24

  12. Efficacy assessed by Iron (Fe)

    Fe will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.

    Measured: Up to Week 24

  13. Efficacy assessed by ferritin

    Ferritin will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.

    Measured: Up to Week 24

  14. Efficacy assessed by transferrin

    Transferrin will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.

    Measured: Up to Week 24

  15. Efficacy assessed by total iron binding capacity

    Total iron binding capacity will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.

    Measured: Up to Week 24

  16. Efficacy assessed by soluble transferrin receptor

    Soluble transferrin receptor will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.

    Measured: Up to Week 24

  17. Efficacy assessed by transferrin saturation

    Transferrin saturation will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.

    Measured: Up to Week 24

  18. Efficacy assessed by reticulocyte hemoglobin content

    Reticulocyte hemoglobin content will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.

    Measured: Up to Week 24

  19. Quality of life assessed by SF-36

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

    Measured: Up to Week 24

  20. Quality of life assessed by EQ-5D

    EQ-5D: EuroQol 5 Dimension

    Measured: Up to Week 24

  21. Quality of life assessed by FACT-An

    FACT-An: Functional Assessment of Cancer Therapy-Anemia

    Measured: Up to Week 24

  22. Occurrence of hospitalizations

    Measured: Up to Week 24

  23. Safety assessed by incidence of adverse events

    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. Safety assessed by standard 12-lead electrocardiogram

    Measured: Up to Week 24

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

    Measured: Up to Week 24

  27. 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 posted23 May 2016 (estimated)
  2. Study start22 Jun 2016
  3. Primary completion2 Aug 2017
  4. Study completion2 Aug 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02780726
Sponsor's protocol ID
1517-CL-0302
Status last verified
Oct 2024
First submitted
20 May 2016
Last updated
30 Oct 2024
Results posted
No
Data monitoring committee
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

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing roxadustat in people with Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia, run by Astellas Pharma Inc at 15 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 20 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 15 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: Up to 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 NCT02780726, 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 30 Oct 2024.

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