A Study of Intermittent Oral Dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-Naive Hemodialysis Chronic Kidney Disease Patients With Anemia

NCT ID: NCT02780141

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-02
• Study Completion Date: 2017-12-12

Brief Summary

The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive hemodialysis chronic kidney disease patients with anemia.

Conditions

ESA-naive Hemodialysis Chronic Kidney Disease Patients With Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASP1517 Low dose 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

ASP1517 High dose 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

• Mean of the subjects' two most recent Hb values during the Screening Period must be ≤10.0 g/dL with an absolute difference ≤1.0 g/dL between the two values
• Either transferrin saturation (TSAT) ≥ 5% or serum ferritin ≥ 30 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

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 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
• 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) 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 JP00003

Aichi, , Japan

Site JP00005

Aichi, , Japan

Site JP00042

Aichi, , Japan

Site JP00044

Aichi, , Japan

Site JP00020

Chiba, , Japan

Site JP00010

Ehime, , Japan

Site JP00021

Ehime, , Japan

Site JP00013

Fukuoka, , Japan

Site JP00011

Fukushima, , Japan

Site JP00035

Fukushima, , Japan

Site JP00017

Gifu, , Japan

Site JP00033

Gifu, , Japan

Site JP00012

Gunma, , Japan

Site JP00016

Gunma, , Japan

Site JP00025

Gunma, , Japan

Site JP00046

Hiroshima, , Japan

Site JP00015

Hokkaido, , Japan

Site JP00023

Hokkaido, , Japan

Site JP00028

Hokkaido, , Japan

Site JP00038

Hokkaido, , Japan

Site JP00040

Hokkaido, , Japan

Site JP00045

Hokkaido, , Japan

Site JP00034

Hyōgo, , Japan

Site JP00008

Ibaraki, , Japan

Site JP00018

Ibaraki, , Japan

Site JP00027

Ibaraki, , Japan

Site JP00030

Ibaraki, , Japan

Site JP00022

Ishikawa, , Japan

Site JP00041

Kagoshima, , Japan

Site JP00031

Kumamoto, , Japan

Site JP00037

Kumamoto, , Japan

Site JP00009

Nagano, , Japan

Site JP00014

Nagano, , Japan

Site JP00026

Nagano, , Japan

Site JP00047

Nagano, , Japan

Site JP00002

Niigata, , Japan

Site JP00029

Niigata, , Japan

Site JP00039

Okayama, , Japan

Site JP00024

Okinawa, , Japan

Site JP00036

Osaka, , Japan

Site JP00006

Saitama, , Japan

Site JP00032

Shizuoka, , Japan

Site JP00043

Tokushima, , Japan

Site JP00048

Tokyo, , Japan

Site JP00007

Tottori, , Japan

Site JP00019

Toyama, , Japan

Site JP00004

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)

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.

Reference Type: DERIVED

PMID: 36005278 (View on PubMed)

Related Links

https://astellasclinicalstudyresults.com/study.aspx?ID=357

Link to results on Astellas Clinical Study Results website

Other Identifiers

1517-CL-0308

Identifier Type: -

Identifier Source: org_study_id