The goal of this open-label, randomized study is to evaluate the efficacy and safety of the personalized treatment model in which Gd-IgA1 is dynamically monitored to guide medication adjustment in progressive IgAN patients treated with Nefecon or telitacicept.
Researchers will compare two groups of participants: those who have Gd-IgA1 checked regularly during treatment, and those who do not. This is to find out if regular Gd-IgA1 checks can help doctors adjust medication better and get better treatment results.
Male or female, between 18 and 75 years age;
Biopsy confirmed diagnosis of primary IgA nephropathy or IgA Vasculitis-Associated Nephritis;
Persistent proteinuria, defined as: two separate measurements (with an interval of ≥ 4 weeks) of 24-hour urinary protein excretion (24hUTP) ≥ 0.5 g/day, or urine protein-to-creatinine ratio (UPCR) ≥ 0.44 g/g;
Estimated glomerular filtration rate (eGFR) (CKD-EPI) ≥ 30 ml/min per 1.73m²;
Secondary IgA nephropathy (excluding IgA vasculitis) caused by ankylosing spondylitis, systemic lupus erythematosus, viral hepatitis, liver cirrhosis, etc.;
With a known history or clinical evidence of concurrent renal diseases other than IgA nephropathy;
Treating with systemic corticosteroids or immunosuppressants including cyclophosphamide, azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, rituximab, etc. within 3 months prior to randomizing;
Have initiated or had a dose adjustment of leflunomide, tripterygium wilfordii or hydroxychloroquine within 3 months prior to randomizing;
Parallel
Gd-IgA1 monitoring
Diagnostic testParticipants in the experimental group will undergo a total of five Gd-IgA1 tests at baseline and during the follow-up period, and their clinicians will use these results to guide medication adjustment.
Mean change in 24-hour proteinuria from baseline at the end of follow-up
Mean change in 24-hour proteinuria from baseline at the midpoint of follow-up
Change in estimated glomerular filtration rate (eGFR)
eGFR is calculated using the CKD-EPI method.
Complete remission of proteinuria
24-hour urine total protein ≤ 0.3 g with a concurrent eGFR decline ≤ 30%
Immunosuppressant exposure measures
Cumulative dosage of non-corticosteroid immunosuppressants, cumulative dosage of systemic corticosteroids converted to prednisone-equivalent dosage, and number of corticosteroid bolus therapy courses during follow-up. Consecutive daily bolus doses count as one course; topical corticosteroids are excluded.
The incidence rate and severity of adverse events
An adverse event is any undesirable experience associated with the study intervention in a patient.
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Hong Zhang
Lead sponsor
Peking University First Hospital
Sponsor institution
