NCT02952092

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

57 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

November 30, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

October 31, 2016

Last Update Submit

October 29, 2024

Conditions

Hemodialysis Chronic Kidney Disease Patients With Anemia

Keywords

ASP1517Renal anemiaHemodialysisRoxadustat

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the average hemoglobin (Hb)

    Baseline and Weeks 18 to 24

Secondary Outcomes (28)

  • Average Hb from Week 18 to Week 24

    Week 18 to 24

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

    Week 18 to 24

  • Proportion of participants with the target Hb level at each week

    Up to Week 24

  • Change from week 0 in Hb levels to each week

    Up to Week 24

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

    Week 18 to 24

  • +23 more secondary outcomes

Study Arms (2)

ASP1517 Group

EXPERIMENTAL

Subjects will take the study drug at two- or three-day intervals.

Drug: roxadustat

Darbepoetin alfa Group

EXPERIMENTAL

Subjects will take the study drug once a week.

Drug: Darbepoetin alfa

Interventions

roxadustatDRUG

Oral

Also known as: ASP1517
ASP1517 Group
Darbepoetin alfaDRUG

Intravenous

Darbepoetin alfa Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (57)

Site JP00008

Aichi, Japan

Location

Site JP00018

Aichi, Japan

Location

Site JP00020

Aichi, Japan

Location

Site JP00032

Aichi, Japan

Location

Site JP00033

Aichi, Japan

Location

Site JP00040

Aichi, Japan

Location

Site JP00004

Ehime, Japan

Location

Site JP00055

Ehime, Japan

Location

Site JP00009

Fukui, Japan

Location

Site JP00059

Fukui, Japan

Location

Site JP00014

Fukuoka, Japan

Location

Site JP00049

Fukuoka, Japan

Location

Site JP00010

Fukushima, Japan

Location

Site JP00056

Fukushima, Japan

Location

Site JP00057

Fukushima, Japan

Location

Site JP00030

Gifu, Japan

Location

Site JP00050

Gifu, Japan

Location

Site JP00011

Gunma, Japan

Location

Site JP00026

Gunma, Japan

Location

Site JP00037

Gunma, Japan

Location

Site JP00003

Hokkaido, Japan

Location

Site JP00031

Hokkaido, Japan

Location

Site JP00038

Hokkaido, Japan

Location

Site JP00048

Hokkaido, Japan

Location

Site JP00017

Ibaraki, Japan

Location

Site JP00041

Ibaraki, Japan

Location

Site JP00042

Ibaraki, Japan

Location

Site JP00045

Ibaraki, Japan

Location

Site JP00046

Ibaraki, Japan

Location

Site JP00047

Ibaraki, Japan

Location

Site JP00054

Ibaraki, Japan

Location

Site JP00058

Ibaraki, Japan

Location

Site JP00043

Kagoshima, Japan

Location

Site JP00005

Kanagawa, Japan

Location

Site JP00028

Kumamoto, Japan

Location

Site JP00029

Kumamoto, Japan

Location

Site JP00006

Kyoto, Japan

Location

Site JP00002

Nagano, Japan

Location

Site JP00012

Nagano, Japan

Location

Site JP00027

Nagano, Japan

Location

Site JP00051

Nagano, Japan

Location

Site JP00013

Nagasaki, Japan

Location

Site JP00001

Niigata, Japan

Location

Site JP00034

Niigata, Japan

Location

Site JP00036

Okayama, Japan

Location

Site JP00007

Osaka, Japan

Location

Site JP00015

Osaka, Japan

Location

Site JP00016

Saitama, Japan

Location

Site JP00035

Saitama, Japan

Location

Site JP00044

Tokushima, Japan

Location

Site JP00052

Tokyo, Japan

Location

Site JP00053

Tokyo, Japan

Location

Site JP00021

Toyama, Japan

Location

Site JP00022

Toyama, Japan

Location

Site JP00039

Toyama, Japan

Location

Site JP00024

Yamagata, Japan

Location

Site JP00025

Yamaguchi, Japan

Location

Related Publications (3)

  • 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.

    PMID: 38363463DERIVED

  • 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.

    PMID: 36005278DERIVED

  • 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.

    PMID: 32493693DERIVED

Related Links

MeSH Terms

Interventions

roxadustatDarbepoetin alfa

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Medical Director

    Astellas Pharma Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

November 30, 2016

Primary Completion

March 13, 2018

Study Completion

March 15, 2018

Last Updated

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

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/.

Locations

JP(57)