None listed
Conditions
Interventions
This is a phase 3, multi-center, randomized, double-blind, placebo controlled study. The study population consists of subjects with CKD as defined by CKD stages 3, 4, and 5 (eGFR < 60 mL/min/1.73 m2)
45 to < 70 kg): 70 mg
- For weight (≥
70 to ≤
160 kg): 100mg
Study drug will be dosed thrice weekly (TIW) during the treatment period. Initially subjects will be dosed for Hb correction, until subjects achieve central Hb values of ≥
11.0 g/dL and Hb increase from baseline (BL) ≥
1.0 g/dL at two consecutive study visits, separated by at least five days (correction period).
Sponsors
Astellas Pharma Europe B.V.,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria:   1. Informed Consent and privacy language must be obtained from the subject or legally authorized representative 2. Subject age is ≥ 18 years. 3. Subject has a diagnosis of chronic kidney disease, with KDOQI Stage 3, 4 or 5, not receiving dialysis. 4. The mean of the subject’s three most recent Hb values, must be ≤ 10.0 g/dL, with a difference of ≤ 1.0 g/dL between the highest and the lowest values. 5. Ferritin level ≥ 30 ng/mL at screening. 6. Transferrin saturation level ≥ 5% at screening. 7. Serum folate level ≥ lower limit of normal at screening. 8. Serum vitamin B12 level ≥ lower limit of normal at screening. 9. ALT, AST levels are ≤ 3 x upper limit of normal, and total bilirubin is ≤ 1.5 x ULN. 10. Subject’s body weight is 45.0 kg up to a maximum of 160.0 kg. 11. Female subject is either: • Of non-child bearing potential: • If of child bearing potential: - agree not to try to become pregnant during the study and for 28 days after the final study drug administration. - a negative serum pregnancy test at screening, and - agree to use a highly effective form of birth control throughout the study period, and continued for 28 days after the last study treatment administration. 12. Male subject and their female partner who are of childbearing potential must use contraception throughout the study period, and for 12 weeks after final study treatment administration. 13. Subject agrees not to participate in another interventional study until the End of Study (EOS) visit.
Exclusion criteria
Exclusion criteria: First 15 exclusion criteria listed: 1.Received 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.History of myelodysplastic syndrome or multiple myeloma. 5.Known hereditary hematologic disease or other known causes for anemia other than CKD. 6.Subject has a known hemosiderosis, hemochromatosis, coagulation disorder, or hypercoagulable condition. 7.Subject has chronic inflammatory disease that could impact erythropoiesis 8.Subject is anticipated to have elective surgery that is expected to lead to significant blood loss or anticipated elective coronary revascularization. 9.Subject has active or chronic gastrointestinal bleeding. 10.Subject has received any prior treatment with roxadustat or a hypoxia-inducible factor Prolyl Hydroxylase Inhibitor (HIF-PHI). 11.Subject has been treated with iron-chelating agents within 4 weeks prior to randomization. 12.Subject has a history of chronic liver disease (e.g., cirrhosis or fibrosis of the liver) 13.Subject has a known New York Heart Association Class III or IV congestive heart failure. 14.Subject has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (e.g., pulmonary embolism) within 12 weeks prior to randomization. 15.Uncontrolled hypertension
Countries
Belgium, Bulgaria, Colombia, Dominican Republic, Estonia, Georgia, Greece, Guatemala, Hungary, Italy, Panama, Peru, Poland, Romania, Russian Federation, Serbia, South Africa, Spain, Turkey, Ukraine, United Kindgdom
Contacts
Public ContactJose Eduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed