A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia

NCT ID: NCT02964936

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-11
• Study Completion Date: 2018-08-15

Brief Summary

The objective of this study is to evaluate the efficacy and the safety when ASP1517 is intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis chronic kidney disease patients with anemia.

Conditions

Chronic Kidney Disease

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 for 24 weeks and dose adjustments will be made during the study.

Group Type: EXPERIMENTAL

roxadustat

Intervention Type: DRUG

Oral administration

ASP1517 High dose group

Study drug will be dosed three times weekly for 24 weeks and dose adjustments will be made during the study.

Group Type: EXPERIMENTAL

roxadustat

Intervention Type: DRUG

Oral administration

Interventions

roxadustat

Oral administration

Intervention Type: DRUG

Other Intervention Names

ASP1517

Eligibility Criteria

Inclusion Criteria

• Subjects who were diagnosed with non-dialysis chronic kidney disease (CKD) and who are considered not to require renal replacement therapy during the study period
• 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 ≥ 5% or serum ferritin ≥ 30 ng/mL
• Female subject must either:

Be of non-childbearing potential:

• post-menopausal prior to pre-screening, or
• documented surgically sterile Or, if of childbearing potential,
• Agree not to try to become pregnant during the study after informed consent acquisition and for 28 days after the final study drug administration
• And have a negative urine pregnancy test at pre-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 pre-screening and throughout the study period and for 28 days after the final study drug administration.
• Female subject must agree not to breastfeed starting at pre-screening and throughout the study period, and for 28 days after the final study drug administration.
• Female subject must not donate ova starting at pre-screening and throughout the study period, and 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 pre-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 pre-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 pre-screening assessment
• Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the pre-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 ESA, protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the pre-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 pre-screening assessment
• Previous or current malignant tumor (no recurrence for at least 5 years is eligible.)
• Having undergone red blood transfusion and/or a surgical procedure considered to promote anemia within 4 weeks before the pre-screening assessment
• Having undergone a kidney transplantation
• History of serious drug allergy including anaphylactic shock
• Having a previous history of treatment with ASP1517
• 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 JP00029

Numakunai, Iwate, Japan

Site JP00007

Aichi, , Japan

Site JP00018

Aichi, , Japan

Site JP00028

Aichi, , Japan

Site JP00001

Chiba, , Japan

Site JP00035

Ehime, , Japan

Site JP00012

Fukui, , Japan

Site JP00011

Fukuoka, , Japan

Site JP00031

Fukuoka, , Japan

Site JP00030

Hiroshima, , Japan

Site JP00034

Hiroshima, , Japan

Site JP00036

Hiroshima, , Japan

Site JP00005

Hokkaido, , Japan

Site JP00020

Hyōgo, , Japan

Site JP00015

Ibaraki, , Japan

Site JP00017

Ibaraki, , Japan

Site JP00021

Ibaraki, , Japan

Site JP00025

Ibaraki, , Japan

Site JP00037

Ibaraki, , Japan

Site JP00033

Ishikawa, , Japan

Site JP00006

Kanagawa, , Japan

Site JP00014

Kanagawa, , Japan

Site JP00038

Kanagawa, , Japan

Site JP00010

Miyagi, , Japan

Site JP00016

Nagano, , Japan

Site JP00024

Niigata, , Japan

Site JP00003

Osaka, , Japan

Site JP00009

Osaka, , Japan

Site JP00026

Osaka, , Japan

Site JP00032

Ōita, , Japan

Site JP00002

Saitama, , Japan

Site JP00019

Saitama, , Japan

Site JP00027

Saitama, , Japan

Site JP00004

Tokyo, , Japan

Site JP00013

Tokyo, , Japan

Site JP00022

Tokyo, , Japan

Site JP00023

Tokyo, , Japan

Site JP00008

Toyama, , Japan

Countries

Japan

Related Links

https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=399

Link to results on the Astellas Clinical Study Results website.

Other Identifiers

1517-CL-0314

Identifier Type: -

Identifier Source: org_study_id