a study of molidustat for treatment of renal anemia in peritoneal dialysis subjects

Conditions: Anemia; Renal Insufficiency, Chronic

Summary: the purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia


Eligibility criteria:
inclusion criteria: * subject with end-stage kidney disease (eskd) on peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period * body weight \> 40 and ≤ 160 kg at screening * male or female subject ≥ 20 years of age at screening * at least one kidney * subjects who meet one of the 1 or 2 following criteria * subjects untreated with esa at assignment: mean of the last 2 hb level (central laboratory measurement) during the screening period must be ≥ 8.0 and \< 11.0 g/dl (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be \< 1.2 g/dl) with the last screening hb measurement within 14 days prior to study drug assignment * subjects pre treated with esa at assignment: mean of the last 2 hb level (central laboratory measurement) during the screening period must be ≥ 10.0 and \< 13.0 g/dl (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be \< 1.2 g/dl) with the last screening hb measurement within 14 days prior to study drug assignment * subjects who meet one of the 1 or 2 following criteria * subjects untreated with esa at assignment: subject with eskd on peritoneal dialysis for at least 2 weeks prior to assignment. and. subject not received esa for 8 weeks prior to assignment. or. in case of the patient washed out from esas, when mean of the last 2 hb level (at least 2 central laboratory measurements must be taken ≥ 2 days apart) has decrease to ≥ 0.5g/dl from the hb level (central laboratory measurement) after the last esa administration, and the interval from the last esa administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol * subjects pre treated with esa at assignment: * subject with eskd on peritoneal dialysis for at least 12 weeks prior to assignment * subject treated with esa by iv or sc within 8 weeks prior to assignment * treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, or 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment exclusion criteria: * new york heart association (nyha) class iii or iv congestive heart failure * history of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization * sustained and poorly controlled arterial hypertension (defined as systolic bp≥ 180mmhg or diastolic bp ≥ 110mmhg) or hypotension (defined as systolic bp \< 90mmhg) at randomization * proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)