a study of intermittent oral dosing of asp1517 in esa-untreated chronic kidney disease patients with anemia

Conditions: Chronic Kidney Disease

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 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

Keywords: anemia non-dialysis chronic kidney disease roxadustat asp1517