IgA nephropathy
Conditions
Interventions
Test group:Basic treatment regimen + targeted B-cell biologics (tetracycline)
Basic treatment regimen: including but not limited to RAS blockers, hormones, immunosuppressants and/or supportive therapy
Targeted B-cell biologic: tetracycline 80 mg subcutaneously, QW, for 24 weeks.
Continuous administration until confirmed disease progression (PD), intolerable toxicity, subject-initiated withdrawal, a
Sponsors
Tianjin Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pathological diagnosis of IgAN by renal biopsy; 2. After receiving basic treatment regimens such as hormones, immunosuppressants, and/or supportive therapy for >= 90 days, urinary protein quantification still exceeds 1.00 g/d; 3. Gender unlimited, age >= 18 years old; 4.Pregnancy tests for women of childbearing age are negative and they are willing to take contraceptive measures (hormone based contraceptives are not allowed); 5. The patient and their family members agree and sign the informed consent form for this study.
Exclusion criteria
Exclusion criteria: 1.Secondary IgA patients, including: allergic purpura, ankylosing spondylitis, systemic lupus erythematosus, etc.; 2.Patients with other types of glomerular diseases such as crescentic nephritis (pathological diagnosis>50%), minimal degenerative nephropathy with IgA deposition, etc.; 3.Patients with the following cardiovascular and cerebrovascular events within 24 weeks: myocardial infarction, unstable angina, ventricular arrhythmias, heart failure with NYHA grade II or above, moderate stroke; 4.Type 1 or type 2 diabetes patients with poor control (glycosylated hemoglobin>8%); 5.Patients with poor drug compliance, incomplete follow-up data, or inability to follow up regularly; 6.Patients who receive hospitalization or intravenous anti infection treatment for active infections within 4 weeks; 7.Patients with active tuberculosis and untreated latent tuberculosis; 8.Patients with combined infections such as HBV, HCV, syphilis, and HIV; 9.Patients undergoing kidney transplantatio; 10.Patients with allergies to human derived biological products; 11.Patients who have used CD20 antibody drugs within 24 weeks; 12.Patients who cannot avoid using nephrotoxic drugs; 13.Patients with drug or alcohol abuse/dependence; 14. Pregnant, lactating, or recently planned to have children; 15.Patients with psychological disorders and loss of behavioral ability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum creatinine;24-hour urine protein quantification;Albumin;Protein;Urine occult blood; | — |
Countries
China
Contacts
Public ContactDingwei Yang
Tianjin Hospital
Outcome results
None listed