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A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3, Multicenter, Randomized, 2-Arm, Open-label Study of Intermittent Oral Dosing of ASP1517 for the Treatment of Anemia in Erythropoiesis Stimulating Agent-untreated Chronic Kidney Disease Patients Not on Dialysis

NCT02964936•Astellas Pharma Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

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
+6 more criteria

Locations (38)

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

Key Dates

Start Date

January 11, 2017

Primary Completion Date

August 15, 2018

Completion Date

August 15, 2018

Last Updated

October 31, 2024

Enrollment

100

ACTUAL participants

Conditions

Chronic Kidney Disease

Interventions

roxadustat

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

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Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

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