Study of Telitacicept in Patients With Refractory IgA Nephropathy

Inclusion criteria

• Voluntarily sign the informed consent form.
• IgA nephropathy was confirmed by pathological biopsy.
• Age range: ≥ 18 years old, ≤ 70 years old, male or female.
• During the screening period, the 24-hour urine protein of Visit 1 and Visit 2 should meet at least one ≥0.75g/24h, and the 24-hour urine protein ≥ 0.75g/24h at Visit 3.
• Measured glomerular filtration rate or estimated GFR (using the CKD-EPI formula) > 35 mL/min/1.73 m2.
• Participants had received a basic regimen including ACE inhibitors/ARBs for 12 weeks prior to randomization, and the dose of ACE inhibitors/ARBs (within the maximum tolerated range) was stable for 4 weeks prior to randomization.

Exclusion criteria

• Abnormal laboratory indicators of participants need to be excluded.
• Secondary IgA nephropathy need to be excluded.
• Specific pathologic or clinical renal disease types, and IgA nephropathy that may require hormone therapy.
• Patients who have experienced any of the following cardiovascular and cerebrovascular events within the 12 weeks prior to screening.
• Use of systemic corticosteroids within 3 months prior to randomization (except local, nasal inhalation, etc.)
• Immunosuppressants were used within 3 months prior to randomization.
• Patients requiring hospitalization for active infection or intravenous anti-infective therapy within 3 months prior to randomization.
• Previously or currently diagnosed active tuberculosis Untreated latent tuberculosis.
• Herpes zoster HIV antibody positive or HCV antibody positive during the screening period.
• Those who currently have active hepatitis or have severe liver disease and medical history.
• Patients with malignant tumors.
• Pregnant and lactating women, and men or women with planned children during the trial period.
• Those who could not avoid the use of nephrotoxic drugs during the trial.
• Allergic to human biological products.
• Patients who have been given any of the clinical trial drugs 4 weeks prior to randomization or within 5 times the half-life of the experimental drug (whichever is longer).
• Patients deemed ineligible for the trial by the investigator.