| Participants |
General information
Setting: multicentre Country: multinational (South Korea, Thailand, Bulgaria, Poland, Ukraine, Chile, Philippines, Taiwan, Estonia, Romania, Australia; Colombia, Malaysia, Belarus, Latvia, Russia, Argentina, Mexico) Inclusion criteria: ≥ 18 years; been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines; receiving HD or PD for native kidney failure for a minimum of 2 weeks and a maximum of 4 months, prior to randomisation; HD access consisting of an AVF, AV graft, or tunnelled (permanent) catheter, or PD catheter in use; mean of the 3 most recent Hb values during the screening period, obtained at least 4 days apart, must be ≤ 10.0 g/dL, with a difference of ≤ 1.3 g/dL between the highest and the lowest values, the last Hb value must be drawn within 10 days prior to randomisation; ferritin ≥ 50 ng/mL; TSAT ≥ 10%; serum folate level, performed within 8 weeks prior to randomisation ≥ LLN; serum vitamin B12 level, performed within 8 weeks prior to randomisation ≥ LLN; ALT or AST ≤ 3 times ULN, and total bilirubin < 1.5 times ULN; body weight 45 to 160 kg (dry weight) Exclusion criteria: any ESA treatment within 12 weeks prior to randomisation; more than one dose of IV iron within 4 weeks prior to randomisation; RBC transfusion within 8 weeks prior to randomisation; active, clinically significant infection that could be manifested by WBC count > ULN, and/or fever, in conjunction with clinical signs or symptoms of infection; history of chronic liver disease (e.g. chronic infectious hepatitis, chronic auto‐immune liver disease, cirrhosis, or fibrosis of the liver); NYHA class III or IV congestive heart failure; MI, acute coronary syndrome, stroke, seizure, or a thromboembolic event (e.g. DVT or pulmonary embolism) within 12 weeks prior to randomisation; uncontrolled hypertension, in the opinion of the investigator, (e.g. that requires change in anti‐hypertensive medication) within 2 weeks prior to randomisation; kidney ultrasound performed within 12 weeks prior to randomisation indicative of a diagnosis or suspicion of renal cell carcinoma; history of malignancy, except for cancers determined to be cured or in remission for ≥ 5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps; positive for HIV, HBsAg, or Anti‐HCV Ab; chronic inflammatory disease that could impact erythropoiesis (e.g. SLE, rheumatoid arthritis, coeliac disease) even if it is currently in remission; known, untreated proliferatives diabetic retinopathy, diabetic macular oedema, macular degeneration, or retinal vein occlusion; known history of myelodysplastic syndrome or multiple myeloma; known hereditary haematologic disease such as thalassaemia or sickle cell anaemia, PRCA, or other known causes for anaemia other than CKD; known haemosiderosis, haemochromatosis, coagulation disorder, or a hypercoagulable condition; any prior organ transplant (that has not been explanted), or a scheduled organ transplantation; anticipated elective surgery, except for vascular access surgery or dialysis catheter placement, that is expected to lead to significant blood loss, or anticipated elective coronary revascularization; known, active or chronic GI bleeding; any prior treatment with FG‐4592 or a HIF‐PHI; use of iron‐chelating agents within 4 weeks prior to randomisation; known hypersensitivity reaction to any ESA; use of an investigational drug or treatment, participation in an investigational study, or presence of an expected carryover effect of an investigational treatment, within 4 weeks prior to randomisation; anticipated use of dapsone in any dose amount or chronic use of acetaminophen or paracetamol > 2.0 g/day during the treatment or follow‐up periods of the study; history of alcohol or drug abuse within 2 years prior to randomisation; females of childbearing potential, unless using contraception as detailed in the protocol; male subjects with sexual partners of childbearing potential who are not on birth control unless the male subject agrees to use contraception; pregnant or breastfeeding females; any medical condition, that in the opinion of the investigator, may pose a safety risk to a subject in this study, may confound efficacy or safety assessment, or may interfere with study participation Target Hb: not reported CKD stage: HD and PD
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