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

• Status: Completed
• Trial end date: 2018-08-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: FibroGen

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