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

Astellas

Status and phase

Completed

Phase 3

Conditions

ESA-naive Hemodialysis Chronic Kidney Disease Patients With Anemia

Treatments

Drug: roxadustat

Study type

Interventional

Funder types

Industry

Identifiers

NCT02780141

1517-CL-0308

Details and patient eligibility

About

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

Enrollment

75 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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