Status:
RECRUITING
Efficacy and Safety of Telitacicept in IgAN
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
RenJi Hospital
Conditions:
IgA Nephropathy (IgAN)
Kidney Diseases
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.
Detailed 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 pathogenes...
Eligibility Criteria
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 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.
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 as cyclophosphamide, 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, 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.
- 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 blood pressure>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 the study.
- Other reasons judged by researchers as unsuitable for inclusion in the study.
Key Trial Info
Start Date :
December 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06654596
Start Date
December 6 2024
End Date
December 1 2026
Last Update
January 1 2025
Active Locations (1)
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1
Ruijin Hospital
Shanghai, China, 200025