Efficacy and Safety of Telitacicept in IgAN

Phase

N/A

Condition

Glomerulonephritis

Treatment

Glucocorticoid

Telitacicept 240mg

Clinical Study ID

NCT06654596

TETA-IgA

Ages 18-70
All Genders

Study Summary

A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 drugdose (within the maximum tolerated range) was stable within 4 weeks beforerandomization.
Use of SGLT2, MRA, hydroxychloroquine, and etc. remained unchanged.
Voluntarily participated in this study and signed the informed consent form.

Exclusion

Exclusion Criteria:

Patients with abnormal laboratory indicators (see study protocol for details).
Secondary IgA nephropathy such as Henoch-Schonlein purpura, SLE, cirrhosis, etc.
Use of systemic glucocorticoids/immunosuppressants within 3 months (such ascyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus,cyclosporine, tripterygium wilfordii, etc.).
Use of biological agents within 6 months (rituximab, etc.).
Active infection, such as active tuberculosis, active hepatitis, hepatitis C, herpeszoster, HIV, etc. According to the results of the five hepatitis B test: patientswith positive HBsAg should be excluded; patients with negative HBsAg but positiveHBcAb, regardless of whether HBsAb is positive or negative, need to test HBV-DNA todetermine 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.
COVID-19 infection within 2 weeks before randomization.
Live vaccine within 4 weeks before randomization.
History of malignant tumor within five years.
Uncontrolled hypertension (systolic blood pressure>140mmHg or diastolic bloodpressure>90mmHg).
Poorly controlled diabetes (glycosylated hemoglobin>8%).
Pregnant women and breastfeeding women.
Participating in other clinical trials at the same time.
Surgery, chemotherapy, radiotherapy and other treatments are planned during thestudy.
Other reasons judged by researchers as unsuitable for inclusion in the study.

Study Design

Glucocorticoid

December 06, 2024

December 31, 2026

Study Description

IgA nephropathy is a glomerulonephritis characterized by pathological IgA deposition in the mesangial region. Its clinical and pathological manifestations are diverse and heterogeneous. Its pathogenesis has not yet been fully clarified, and there is currently no unified treatment plan. As a recombinant human B lymphocyte stimulator receptor-antibody fusion protein, telitacicept has become a new therapeutic target. The results of the Phase II clinical trial of this drug for IgA nephropathy have already been published. It is one of the key pioneering clinical studies in the field of IgA nephropathy treatment. The study showed that telitacicept can effectively reduce patients' proteinuria and reduce the risk of disease progression. Based on the above research results, the investigators plan to conduct a multicenter, randomized, controlled clinical study to evaluate the efficacy and safety of telitacicept in the treatment of primary IgA nephropathy patients with a high risk of progression.

Connect with a study center

Ruijin Hospital
Shanghai, 200025
China
Active - Recruiting

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