Overview
The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy.
Description
This study consists of a 5-week screening period, a double-blind treatment period divided into phase A and phase B. Eligible subjects will be randomly assigned in a 1:1 ratio to receive either Telitacicept 240mg or placebo. Subjects will be given SC Telitacicept or placebo once a week for a total of 39 doses in phase A and once every 2 weeks for a total of 32 doses in phase B.
Primary endpoint of phase A will be measured at week 39. Primary endpoint of phase B will be measured at week 104.
Eligibility
Inclusion Criteria:
- Voluntary informed consent provided;
- Male or female aged ≥ 18 years old;
- IgA nephropathy confirmed by pathological biopsy;
- During the screening period, UPCR ≥ 0.5 g/g based on 24-hour urine collection at visit 1 and/or visit 2 and at visit 3;
- eGFR ≥ 30 mL/min per 1.73 m^2 (using the CKD-EPI);
- Have been on a treatment regimen including ACEI/ARB for 12 weeks and on a stable use of ACEI/ARB medication at the maximum tolerated dose/maximum allowable dose within 4 weeks prior to randomization. Subjects who use both ACEIs and ARBs will be excluded.
Exclusion Criteria:
- Subjects with clinically significant abnormal laboratory tests;
- Patients with secondary IgA nephropathy;
- Patients with other types of glomerular disease such as crescentic glomerulonephritis, minimal change nephropathy with IgA deposition;
- Renal transplant;
- Patients with cirrhosis, as assessed by the investigator;
- Patients who experienced any of the following cardiovascular and cerebrovascular events within 24 weeks prior to randomization: myocardial infarction, unstable angina, ventricular arrhythmia, NYHA Class II or higher heart failure, stroke, etc.;
- Sitting office SBP>140 mmHg or DBP>90 mmHg during the screening period;
- HbA1c>8% (64mmol/mol);
- Treatment with immunosuppressants (cyclophosphamide, azathioprine, mycophenolate, leflunomide, tacrolimus, cyclosporine, Tripterygium wilfordii, etc.) within 12 weeks prior to randomization;
- Treatment with anti-CD20 therapy within 24 weeks prior to randomization;
- Treatment with systemic glucocorticoid within 12 weeks prior to randomization;
- Hospitalization or intravenous anti-infective therapy for active infection within 4 weeks prior to randomization;
- Patients with active tuberculosis and untreated latent tuberculosis;
- Hepatitis B: patients with active hepatitis (patients with positive HBsAg) or latent hepatitis B (patients with positive HBcAb and positive HBV-DNA);
- Patients with hepatitis C;
- Patients with HIV;
- Patients with malignancy within the past 5 years, except for treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, colon polyps, or cervical cancer in situ;
- Pregnant women, lactating women, and subjects with childbearing plans during the trial;
- Unavoidable use of drugs with renal toxicity during the study;
- Allergic to biological products of human origin;
- Patients who have received any investigational therapy within 4 weeks or within 5 times the half-life of the investigational product (whichever is longer) prior to randomization;
- Live vaccination within 4 weeks prior to randomization;
- Patients with COVID-19 infection within 4 weeks of randomization or patients with a history of serious COVID-19 disease requiring hospitalization within 52 weeks prior to screening;
- Drug or alcohol abuse/dependence within 52 weeks prior to randomization;
- Not suitable for the study in the opinion of the investigator.
