Chronic Kidney Disease
Conditions
Interventions
Study arm:1-step lower weight-based starting dose group: = 60 kg: 70 mg TIW
Control arm:Control arm: standard weight-based starting dose group: = 60 kg: 100 mg TIW
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Ages 18 to 75 years (inclusive). 2.Subject has voluntarily signed and dated an informed consent form, approved by an Ethics Committee, after the nature of the study has been explained and the subject has had the opportunity to ask questions. 3.Diagnosis of chronic kidney disease stage 3-5 patients with an estimated glomerular filtration rate (eGFR) = 70 to <100g/L. 5.A minimum body weight of 40 kg (inclusive). 6.Subjects agreeing not to start taking any new Traditional Chinese Medicine (TCM) for anemia and not to change dose, schedule, or brand of any prescreening TCM for anemia from beginning of Screening Period through end of Follow-up Period without approval of the FibroGen China Medical Monitor.
Exclusion criteria
Exclusion criteria: 1.Positive for human immunodeficiency virus antibody (HIV-Ab), or positive for hepatitis B surface antigen (HBsAg) and HBV NDA level higher than limits of detection, or positive for anti-hepatitis C virus antibody (HCV-Ab) and HCV RNA level higher than limits of detection, or a scheduled anti-virus treatment for HBV and HCV . 2.New York Heart Association Class III or IV congestive heart failure at screening. 3.Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (e.g., deep venous thrombosis or pulmonary embolism) within 26 weeks prior to Day 1. 4.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, or in situ cancer at any site. 5.Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosis [SLE], rheumatoid arthritis, celiac disease). 6.Clinically significant active gastrointestinal bleeding (e.g. stool occult bleeding test positive for patient without taking oral iron or >= ++ for patients receiving oral iron). 7.Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition. 8.Received organ transplant within 6 years or a scheduled organ transplantation. 9.Anticipated elective surgery that could lead to significant blood loss during the study period. 10.Anticipated renal replacement therapy within 6 months by investigators discretion. 11.Deferoxamine, deferiprone, or deferasirox therapy within 12 weeks prior to Day 1 or anticipated use during the treatment period. 12.Life expectancy of 3 x upper limit of normal (ULN) or total bilirubin > 1.5 x ULN at screening and baseline visit except for subjects with known Gilberts syndrome. 18.Ferritin < 100 ng/mL. 19.Use of an investigational medication or treatment, participation in an investigational interventional study within 28 days prior to day 1, or carryover effect of an investigational treatment expected during the study. 20.Women who are pregnant or breastfeeding. 21.Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception. 22.Any medical condition, e.g. including active, clinically significant infection, decompensated cirrhosis and so on, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Hb level from baseline to average over weeks 12-16; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with average Hb (weeks 12-16) between 100-120 g/L;Proportion of subjects who received rescue therapy (composite of blood transfusion, ESA use, and IV iron) from 5 weeks on since first day of treatment, and time to rescue therapy from date of first dose during study treatment ;Hb variability; | — |
Countries
China
Contacts
Public ContactChen Xiangmei
Chinese PLA General Hospital
Outcome results
None listed