Refractory IgA nephropathy (IgAN) and IgA vasculitis nephritis (IgAVN)
Conditions
Interventions
Tasimipide treatment group:Tasimacicab therapy
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Inclusion criteria
Inclusion criteria: (1) Age range: 5 - 18 years old, gender not restricted; (2) Diagnosed with refractory IgAN or IgAVN, defined as patients who were confirmed to have IgAN or IgAVN through renal biopsy, despite receiving treatment with ACE inhibitors (ACEis), corticosteroids or immunosuppressants for at least 3 months, still having proteinuria > 0.5g/1.73m2/day or recurrent gross hematuria, and being intolerant to glucocorticoids (intolerance is defined as elevated intraocular pressure, cataracts, etc.); (3) Estimated glomerular filtration rate (eGFR) calculated by Schwartz formula is greater than 45 mL/min/1.73 m^2. (4) Patients and their parents signed the informed consent form.
Exclusion criteria
Exclusion criteria: If any of the following conditions is met, the subject must be excluded from this study: (1) No severe organ damage caused by non-IgAN or IgAVN. (2) Suffering from severe or chronic infections, or having a history of repeated infections. (3) Allergic to humanized biological agents. (4) Complicated with other autoimmune diseases or malignant tumors. (5)Psychiatric disorders or cognitive impairments, making it impossible to cooperate with treatment and follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour urine protein level changes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine protein-to-creatinine ratio;eGFR;Urine red blood cell level;Serum albumin level;Serum immunoglobulin levels;Plasma APIRL levels;levels of galactose-deficient IgA (Gd-IgA1);Changes in the count of peripheral blood CD19+ B lymphocyte subsets;The reduction in prednisone dosage; | — |
Countries
China
Contacts
Public ContactJiang Hongkun
The First Hospital of China Medical University
Outcome results
None listed