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

NCT02779764 | Completed Phase 3

• 1 other identifier: 1517-CL-0312
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 25

Brief 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.

Conditions

Hemodialysis Patients With Renal Anemia

Keywords

Hemodialysis; ASP1517; Roxadustat; Renal anemia

Outcome Measures

Primary Outcomes (1)

• Hemoglobin (Hb) Response Rate from Week 18 to Week 24

  Hb response defined as average Hb within the target range

  Week 18 to 24

Secondary Outcomes (27)

• Hb Response Rate from Week 46 to Week 52

  Week 46 to 52

• Average Hb from Week 18 to Week 24

  Week 18 to Week 24

• Average Hb from Week 46 to Week 52

  Week 46 to Week 52

• Change from baseline in the average Hb from Week 18 to Week 24

  Baseline and Weeks 18 to 24

• Change from baseline in the average Hb from Week 46 to Week 52

  Baseline and Weeks 46 to 52

Study Arms (1)

ASP1517 Group

EXPERIMENTAL

Study drug will be dosed three times weekly and dose adjustments will be made during the study.

Drug: roxadustat

Interventions

roxadustat DRUG

Oral

Also known as: ASP1517

ASP1517 Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Kyntra Bio: collaborator

Study Sites (25)

Site JP00017

Aichi, Japan

Location

Site JP00005

Fukuoka, Japan

Location

Site JP00004

Gunma, Japan

Location

Site JP00006

Gunma, Japan

Location

Site JP00018

Hokkaido, Japan

Location

Site JP00019

Hokkaido, Japan

Location

Site JP00021

Hokkaido, Japan

Location

Site JP00023

Hyōgo, Japan

Location

Site JP00008

Ibaraki, Japan

Location

Site JP00020

Ishikawa, Japan

Location

Site JP00010

Kumamoto, Japan

Location

Site JP00022

Kumamoto, Japan

Location

Site JP00024

Kumamoto, Japan

Location

Site JP00016

Kyoto, Japan

Location

Site JP00002

Nagano, Japan

Location

Site JP00012

Nagano, Japan

Location

Site JP00015

Nagano, Japan

Location

Site JP00003

Niigata, Japan

Location

Site JP00025

Osaka, Japan

Location

Site JP00007

Saitama, Japan

Location

Site JP00009

Shizuoka, Japan

Location

Site JP00014

Tokyo, Japan

Location

Site JP00013

Tottori, Japan

Location

Site JP00011

Wakayama, Japan

Location

Site JP00001

Yamaguchi, Japan

Location

Related Publications (1)

• 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: 38363463 DERIVED

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Interventions

roxadustat

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 20, 2016
• Study Start: May 16, 2016
• Primary Completion: May 16, 2017
• Study Completion: November 28, 2017
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

JP (25)