IgA nephropathy
Conditions
Interventions
Taitasip + Hormone Group :Hormone therapy with hormone group, on this basis plus Taitancept 240 mg, subcutaneous injection, 1 / week, a total of 12 weeks, according to the patients wishes, if willing
Taitasip Group:Single use of Taitancept 240 mg, subcutaneous injection, 1 / week, a total of 12 weeks, according to the patients wishes, if willing to continue to use at their own expense, can continu
Hormone Group:The starting dose of prednisone acetate tablets was 0.5 mg / kg / d (maximum dose 40 mg / d) or methylprednisolone 0.4 mg / kg / d (maximum dose 32 mg / d). For 8 weeks, then reduce pred
Sponsors
The First Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary informed consent; 2. Pathological biopsy confirmed IgA nephropathy; 3. Age >= 18 years, = 1 g; 5. The estimated glomerular filtration rate (eGFR, using the CKD-EPI formula) > 30 mL / min / 1.73 m^2.
Exclusion criteria
Exclusion criteria: 1. Exclusion of abnormal lab parameters, including but not limited to: a. White blood cell count 1.5 × ULN;E. glutaminotransferase > 3 × ULN;F. glutamate aminotransferase > 3 × ULN;G. Alkaline phosphatase > 2 × ULN;H. creatine kinase > 5 × ULN. 2. Exclusion of secondary IgA nephropathy, including Henoch-Schonlein purpura, ankylosing spondylitis, SLE, Sjogren's syndrome, viral hepatitis, cirrhosis of liver, rheumatoid arthritis, and mixed connective tissue disorders; 3. Exclude special pathological or clinical renal diseases such as nephrotic syndrome, crescentic glomerulonephritis (> 50% crescentic glomerulonephritis), minimal change nephropathy with IgA deposition; 4. Any of the following cardiovascular and cerebrovascular events: myocardial infarction, unstable angina pectoris, ventricular arrhythmias, New York Heart Association grade II or above heart failure, stroke, etc. 5. At least one outpatient sitting SBP > 140 mmHg in 2 visits during the screening period;DBP>90 mmHg; 6. Persons with diabetes mellitus (both type I and type II); 7. BMI >28 kg/m2; 8. Systemic use of immunosuppressive biologics, including rituximab, belimumab, otocilizumab, acercept, and teratacept, within 12 weeks prior to the first dose; 9. Treatment with systemic corticosteroids within 12 weeks prior to the first dose, excluding the use of systemic corticosteroids not exceeding 7.5 mg / day of prednisone or equivalent doses of other drugs of the same type; 10. Patients with active infection requiring hospitalization or intravenous anti-infective therapy within 4 weeks before the first dose; 11. Persons with active tuberculosis and those with untreated tuberculosis in the incubation period; 12. Patients with active hepatitis or viral hepatitis in the incubation period (including HBsAg positive, HBcAb positive and HBV-DNA positive, HCV-RNA positive); 13. History of immunodeficiency diseases or positive results of HIV tests (enzyme-linked immunosorbent assay and western blot); 14. Patients diagnosed with a malignant tumor within the last 5 years; 15. Patients receiving a kidney transplant; 16. Pregnant women, lactating women and men or women who have planned to have children during the trial period; 17. Patients who cannot avoid the use of nephrotoxic drugs during the trial; 18. People who are allergic to human-derived biological products; 19. Persons who have been given any clinical trial drug within 4 weeks before the initial administration or 5 times the half-life of the trial drug, whichever is earlier; 20. Patients with low immune function (serum IgG level<4g/L); 21. Subjects that the investigator considers unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 hour urine protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| eGFR;UACR;Urine red blood cell count;Immunoglobulin;Gd-IgA1; | — |
Countries
China
Contacts
Public ContactXu Guoshuang
The First Affiliated Hospital of Air Force Medical University
Outcome results
None listed