Renal anemia
Conditions
Interventions
HIF-PHI treatment group:Hypoxia inducible factorprolylhydroxylase inhibitor
Control Group:None
Sponsors
The First Affiliated Hospital Zhejiang University College of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-75 years; 2.Uremia patients have received kidney transplantation for at least 6 months, and the anti-rejection regimen was tacrolimus + mycophenolate mofetil + hormones, with hormone maintenance dose of 5-10mg/d; 3.Patients with stable renal function in recent 3 months (fluctuation range of Serum creatinine in recent 3 months is less than 20%) and no evidence of acute or chronic rejection; 4.Patients had not received erythropoietic stimulant therapy at least 4 weeks before randomization; 5.During screening, the mean hemoglobin level for patients was 8g/dL-<11g/dL for the last 3 times; 6.Subjects voluntarily participate, voluntarily sign the informed consent approved by the Ethics Committee and indicate the date.
Exclusion criteria
Exclusion criteria: 1.Delayed recovery, acute and chronic rejection after kidney transplantation, as well as receiving dialysis again for any reason; 2.Multiple organ transplantation or secondary kidney transplantation; 3.Evidence of clinically significant infection or active potential infection; 4.Patients receiving cyclosporine anti-rejection therapy; 5.Patients were definitely diagnosed infected with parvovirus B19; 6.Positive for human immunodeficiency virus, hepatitis B surface antigen or anti-hepatitis C virus antibody; 7.Chronic liver disease; 8.New York Heart Association Class III or IV congestive heart failure; 9.Myocardial infarction, acute coronary syndrome, stroke, epilepsy, or thromboembolism within 52 weeks; 10.Hypertension is not under control; 11.Diagnosis or suspicion of renal cell carcinoma; 12.A history of malignant neoplasms, other than cancer that has been determined to be cured or in remission for five years, basal cell or squamous cell skin cancer that has been surgically excised, or carcinoma in situ at any site; 13.Chronic inflammatory diseases other than glomerulonephritis that may affect erythropoiesis (e.g., rheumatoid arthritis, celiac disease, etc.); 14.Gastrointestinal bleeding in clinical sense; 15.A history of known myelodysplastic syndrome, multiple myeloma, hereditary blood disorders (such as thalassemia, sickle cell anemia, pure red cell aplastic anemia), hemosiderosis, hemochromatosis, known coagulation disorders, and anemia from other known causes; 16.There were expected elective surgeries during the study period that could result in massive blood loss; 17.Dapsone or acetaminophen >2.0g/ day or >500 mg/dose is expected to be used, repeated every 6 hours for more than 3 days; 18.Serum albumin <2.5g/dL; 19.Androgen, ferroamine, deferidone, or iron remover within 12 weeks; 20.Life expectancy <12 months; 21.Blood transfusion or expected need for blood transfusion within 12 weeks; 22.Intravenous iron supplementation and/or unwillingness to suspend intravenous iron treatment during screening; 23.Women during pregnancy and breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hhemoglobin;Iron metabolism index;Renal function;HIF-PHI concentation; | — |
Countries
China
Contacts
Public ContactHuang Hongfeng
The First Affiliated Hospital Zhejiang University College of Medicine
Outcome results
None listed