NCT07822100 To Assess the Efficacy and Safety of Utilizing Galactose-deficient IgA1 Biomarker Changes to Guide Pathogenic IgA-targeted Therapeutic Strategies

Eligibility & Interventions

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This trial targets 374 participants in total. It began in 2026-08-24 with a primary completion date of 2028-02.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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 1.73m\^2; * Have received the angiotensin converting enzyme Inhibitors(ACEI) / angiotensin receptor blocker(ARB) standard treatment for 4 weeks prior to randomization; * Intending to receive or having received Nefecon or telitacicept treatment for ≤ 2 weeks at the time of screening. Exclusion Criteria: * 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; * Active tuberculosis or latent carrier without treatment; * Herpes zoster infected patients or patients with positive HIV antibody, positive HCV antibody or HBV infection (According to the HBV screening test, a) the HBsAg-positive; b) HBsAg-negative and HBcAb-positive, the HBV-DNA should be tested to determine the situation: the HBV-DNA positive subjects should be excluded, while the HBV-DNA negative subjects can participated in.) * Suffering from following gastrointestinal diseases: gastric ulcer bleeding within the past 6 months, active inflammatory bowel disease, a history of major gastrointestinal surgery (e.g., gastrectomy, gastroenterostomy, or bowel resection), or pancreatic injury/pancreatitis within the past 6 months; * A confirmed history of osteoporosis or osteonecrosis of the femoral head; * Type 1 or type 2 diabetes with poor glycemic control (HbA1c \> 8%); * Body mass index (BMI) \< 18.5 kg/m².; * Systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg; * Decreased lymphocyte count (absolute value \< 1.1 × 10⁹/L) or decreased immunoglobulin G (IgG \< 6 g/L). * Hepatic dysfunction, meeting any of the following: a) Child-Pugh Class C liver dysfunction; b) ALT or AST \> 2 × upper limit of normal (ULN), or total bilirubin \> 2 × ULN at screening; c) history of hepatic encephalopathy, esophageal varices, or portosystemic shunt surgery; * Evidence of urinary tract obstruction or dysuria. * A history of solid organ transplantation, hematopoietic stem cell/cell/bone marrow transplantation, or kidney transplantation. * Pregnancy, lactation, female participants with childbearing plans during the trial or within 6 months of its completion, and male participants planning to conceive or donate sperm during the trial or within 3 months of its completion; * With a history of malignant tumors within the past 5 years (excluding cutaneous squamous cell carcinoma or basal cell carcinoma); * Allergy to human-derived biologics; * Nephrotoxic drugs is unavoidable during the study period; * Not suitable for the study judged by investigator.

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