None listed
Conditions
Interventions
*20, 50, and 100 mg FG-4592 tablets for oral administration.
Initial Doses:Subjects will receive tiered, weight-based initial doses (Table 2).
Dose Adjustment and Dose Frequency Conversion:
R
Sponsors
FIBROGEN, INC,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age > 18 years 2. Subject has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines 3. Diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4, or 5, not receiving dialysis; with an estimated glomerular filtration rate (eGFR) 30 ng/mL 6. TSAT >5% 7. Serum folate level ≥ lower limit of normal (LLN) 8. Serum vitamin B12 level ≥ lower limit of normal (LLN). 9. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN), and total bilirubin (Tbili) <1.5 x ULN 10. Body weight 45 to 160 kg
Exclusion criteria
Exclusion criteria: 1. Any ESA treatment within 12 weeks prior to randomization 2. More than one dose of IV iron within 12 weeks prior to randomization 3. RBC transfusion within 8 weeks prior to randomization 4. Active, clinically significant infection that could be manifested by white blood cell (WBC) count >ULN, and/or fever, in conjunction with clinical signs or symptoms of infection 5. History of chronic liver disease (e.g. chronic infectious hepatitis, chronic auto-immune liver disease, cirrhosis, or fibrosis of the liver) 6. New York Heart Association Class III or IV congestive heart failure 7. Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization 8. Systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg (confirmed by repeat measurement) within 2 weeks prior to randomization 9. Diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma on renal ultrasound within 12 weeks prior to randomization 10. History of malignancy, except the following: 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 11. Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab) 12. Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission 13. Known untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration and retinal vein occlusion 14. Known history of myelodysplastic syndrome or multiple myeloma 15. Known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD 16. Known hemosiderosis, hemochromatosis, coagulation disorder, or hypercoagulable condition 17. Any prior organ transplant (that has not been explanted), or a scheduled organ transplantation 18. Anticipated elective surgery that is expected to lead to significant blood loss, or anticipated elective coronary revascularization 19. Known active or chronic gastrointestinal bleeding 20. Any prior treatment with FG-4592 or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) 21. Use of iron-chelating agents within 4 weeks prior to randomization 22. Use of an investigational drug or treatment, participation in an investigational study, or presence of expected carryover effect of an investigational treatment, within 4 weeks prior to randomization 23. Anticipated use of dapsone in any dose amount or anticipated chronic use of acetaminophen or paracetamol >2.0 g/day during the treatment or follow-up periods of the study 24. History of alcohol or drug abuse within 2 years prior to randomization 25. Females of childbearing potential, unless using contraception as detailed in the protocol, or sexual abstinence; male subjects with sexual partners of childbearing potential who are not on birth control unless the male subject agrees to use contraception or sexual abstinence 26. Pregnant or breastfeeding females 27. Any medical condition that in the opinion of the investigator may
Countries
Argentina, Australia, Brazil, Chile, Colombia, Korea South, Malasya, Mexico, New Zealand, Philippines, Singapore, Taiwan, Thailand, United States
Contacts
Public ContactANGELA FLORES
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed