A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia

• Status: Completed
• Trial end date: 2017-08-02
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the safety and efficacy of ASP1517 in peritoneal 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:

• 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

• Subjects who have not received Erythropoieses Stimulating Agents (ESAs):

• Subjects who have been receiving peritoneal dialysis for more than 4 weeks before the screening assessment

• Subjects who have never received ESAs after starting peritoneal dialysis, or subjects who have not received ESAs within 6 weeks before the screening assessment.

• 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 (TSAT) ≥ 5% or serum ferritin ≥ 30 ng/mL during the screening period

• Subjects who have been receiving ESAs:

• Subjects with renal anemia who have been receiving ESA within the doses approved in Japan for more than 8 weeks after starting peritoneal dialysis, before the screening assessment

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

• TSAT ≥ 20% or serum ferritin ≥ 100 ng/mL during the screening period

Exclusion Criteria:

• Subjects who had trouble with continuing peritoneal dialysis due to peritonitis, development of catheter trouble (e.g. tunnel infection) within 4 weeks before the screening assessment

• 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), total bilirubin, or Alkaline Phosphatase (ALP) that is greater than the criteria below, 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