Renal Anemia
Conditions
Interventions
Treatment Gorup:Roxadustat Treatment
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Informed consent 1.Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses. The ICF process is described in Appendix A3. Age 2.Patients must be >= 18 and 4 weeks prior to Visit 1 (with a functioning PD catheter in place), and who will continue on PD throughout the duration of the study. 4.ESA naive: Patients who have received either = 5% or serum ferritin >= 30 ng/mL obtained at Screening Visit. 5.ESA treated: Patients who have been receiving ESAs: Patients with renal anemia who have been receiving ESA within the doses approved in China for at least 4 weeks after starting PD, before the screening assessment. -The recent Hb value during the screening period must be >= 70g/L and = 20% or serum ferritin >= 100 ng/mL obtained at Screening Visit. 6.Serum folate level >= lower limit of normal (LLN) obtained from Screening Visit. 7.Serum vitamin B12 level >= LLN obtained from Screening Visit. 8.Alanine aminotransferase or aspartate aminotransferase (AST) <= 3x ULN, and total bilirubin (TBiL) <= 1.5x ULN obtained from Screening Visit. 9.Patients agree not to take any new traditional Chinese medicine (TCM) and not to change, dose, schedule or brand of any TCM from beginning of Screening Period through the end of Follow-up Period. Weight 10.Body weight within 45 to 100 kg (prescribed dry weight, dry weight is defined as weight after draining dialysis fluid for peritoneal dialysis subjects). Reproduction 11.At screening, negative serum pregnancy test for female patients of childbearing potential. Female patients of childbearing potential and male patients (non-surgically sterile, i.e., vasectomy) with a female partner of childbearing potential must, if not practicing complete sexual abstinence, agree to practice a dual method of contraception, for example, a combination of the following: (1) oral contraceptive, depot progesterone or intrauterine device; and (2) a barrier method (condom or diaphragm). Contraceptive methods must be practiced upon being enrolled to the study and until at least 28 days after the last dose of study treatment. Male patients must not donate or bank sperm during this same period.
Exclusion criteria
Exclusion criteria: Medical conditions 1.Patients unlikely to be able to continue PD for the duration of the study according to the Investigators judgement. 2.Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis). 3.History or current diagnosis of Type 1 DM. 4.History of severe, chronic, end-stage, or uncontrolled autoimmune liver disease with ALT > 3 x ULN, or AST > 3 x ULN, or total bilirubin > 1.5 x ULN. 5.Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD. 6.Systolic blood pressure (SBP) >= 160 mmHg or diastolic blood pressure (DBP) >= 95 mmHg (confirmed by repeated measurement), during screening period 7.History or diagnosis of prostate cancer, breast cancer, renal cell carcinoma, or any other 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. 8.Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis or active inflammatory bowel disease that is determined to be the principal cause of anemia. 9.Known hemosiderosis, hemochromatosis or hypercoagulable condition. 10.Any current condition leading to active significant blood loss. 11.New York Heart Association Class III or IV congestive heart failure at enrolment. 12.Acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to start of study treatment. 13.Cognitive disabilities, physical or psychiatric disease that in the opinion of the Investigator/clinician influence the patients adherence and successful completion of the study. 14.Any medical condition, including active, clinically significant infection, that in the opinion of the Investigator or Sponsor may pose a safety risk to a patient in this study, which may confound safety or efficacy assessment or may interfere with study participation. Prior/concomitant therapy 15.Any red blood cell (RBC) transfusion during the Screening Period. 16.Any prior organ transplant or a scheduled organ transplantation date. 17.Having a previous history of treatment with roxadustat or a HIF-PHI within 3 months prior to day 1. Prior/concurrent clinical study experience 18.Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within the 12 weeks preceding the first administration of treatment in this study. 19.Patients with a known hypersensitivity to active substance (roxadustat) or any of the excipients of the product. Other exclusions 20.Involvement in the planning and/or conduct of the study (applies to FibroGen staff and/or staff at the study site). 21.History of alcohol or drug abuse within 2 years prior to start of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| FACT-An scores;SF-36 scores; | — |
Countries
China
Contacts
Public ContactYu Xueqing
Guangdong Provincial People's Hospital
Outcome results
None listed