A Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoieses Stimulating Agent (ESA) Treatment

• Status: Completed
• Trial end date: 2017-11-28
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the efficacy and safety of ASP1517 in hemodialysis patients with renal anemia whose treatment is converted from an Erythropoieses Stimulating Agent formulation.

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: FibroGen
• Treatments: Hematinics

Criteria

Inclusion Criteria:

• Subjects with renal anemia who have been receiving ESA (intravenous treatment) within the doses approved in Japan for more than 8 weeks before the screening assessment

• Mean of the subject's two most recent Hb values during the Screening Period must be ≥10.0 g/dL and ≤12.0 g/dL.

• Either transferrin saturation (TSAT) ≥ 20% or serum ferritin ≥ 100 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 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 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 gastro-paresis

• 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 consider 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