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

NCT ID: NCT02779764

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-16
• Study Completion Date: 2017-11-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASP1517 Group

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

Group Type: EXPERIMENTAL

roxadustat

Intervention Type: DRUG

Oral

Interventions

roxadustat

Oral

Intervention Type: DRUG

Other Intervention Names

ASP1517

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FibroGen

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Site JP00017

Aichi, , Japan

Site JP00005

Fukuoka, , Japan

Site JP00004

Gunma, , Japan

Site JP00006

Gunma, , Japan

Site JP00018

Hokkaido, , Japan

Site JP00019

Hokkaido, , Japan

Site JP00021

Hokkaido, , Japan

Site JP00023

Hyōgo, , Japan

Site JP00008

Ibaraki, , Japan

Site JP00020

Ishikawa, , Japan

Site JP00010

Kumamoto, , Japan

Site JP00022

Kumamoto, , Japan

Site JP00024

Kumamoto, , Japan

Site JP00016

Kyoto, , Japan

Site JP00002

Nagano, , Japan

Site JP00012

Nagano, , Japan

Site JP00015

Nagano, , Japan

Site JP00003

Niigata, , Japan

Site JP00025

Osaka, , Japan

Site JP00007

Saitama, , Japan

Site JP00009

Shizuoka, , Japan

Site JP00014

Tokyo, , Japan

Site JP00013

Tottori, , Japan

Site JP00011

Wakayama, , Japan

Site JP00001

Yamaguchi, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 38363463 (View on PubMed)

Related Links

https://astellasclinicalstudyresults.com/study.aspx?ID=358

Link to results on Astellas Clinical Study Results website

Other Identifiers

1517-CL-0312

Identifier Type: -

Identifier Source: org_study_id