Efficacy and Safety of Telitacicept in IgAN

Korábbi kezelés

• COVID-19 infection within 2 weeks before randomization.
• Live vaccine within 4 weeks before randomization.
• Surgery, chemotherapy, radiotherapy and other treatments are planned during the study.

Más betegség

• Active infection, such as active tuberculosis, active hepatitis, hepatitis C, herpes zoster, HIV, etc. According to the results of the five hepatitis B test: patients with positive HBsAg should be excluded; patients with negative HBsAg but positive HBcAb, regardless of whether HBsAb is positive or negative, need to test HBV-DNA to determine their situation: if HBV-DNA is positive, the patient needs to be excluded; if HBV-DNA is negative, the patient can participate in the trial.
• History of malignant tumor within five years.
• Uncontrolled hypertension (systolic blood pressure>140mmHg or diastolic blood pressure>90mmHg).

Laborértékek

• Patients with abnormal laboratory indicators (see study protocol for details).
• Poorly controlled diabetes (glycosylated hemoglobin>8%).

Egyéb

• Secondary IgA nephropathy such as Henoch-Schonlein purpura, SLE, cirrhosis, etc.
• Use of systemic glucocorticoids/immunosuppressants within 3 months (such as cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, tripterygium wilfordii, etc.).
• Use of biological agents within 6 months (rituximab, etc.).
• Pregnant women and breastfeeding women.
• Participating in other clinical trials at the same time.
• Other reasons judged by researchers as unsuitable for inclusion in the study.

• 18-70 years old, male or female
• Primary IgA nephropathy confirmed by renal biopsy.
• Urine protein ≥ 0.75g/24h or 24-hour urine protein creatinine ratio (PCR) ≥ 0.6 g/g.
• eGFR ≥ 25 ml/min/1.73 m2 calculated using the CKD-EPI formula.
• Received treatment with ACEI/ARB for 12 weeks before randomization, and the drug dose (within the maximum tolerated range) was stable within 4 weeks before randomization.
• Use of SGLT2, MRA, hydroxychloroquine, and etc. remained unchanged.
• Voluntarily participated in this study and signed the informed consent form.