Efficacy and Safety of Telitacicept in IgAN

Launched by RUIJIN HOSPITAL · Oct 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called telitacicept for patients with a kidney condition known as IgA nephropathy (IgAN). IgAN can lead to kidney damage, and this trial aims to see how effective and safe telitacicept is for patients who are at high risk of their condition getting worse. The study is currently recruiting participants who are between 18 and 70 years old and have been diagnosed with primary IgAN through a kidney biopsy. To qualify, participants should have certain levels of protein in their urine and have been on specific blood pressure medications for at least 12 weeks.

If you or someone you know is interested in participating, you can expect to undergo regular health check-ups and monitoring to ensure your safety throughout the trial. However, certain health conditions and recent treatments may prevent participation, including active infections, certain cancers, or recent use of specific medications. Overall, this study is an important step in finding better treatments for IgAN patients, and those who join will be contributing to valuable research that could help many others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18-70 years old, male or female
• • 2. Primary IgA nephropathy confirmed by renal biopsy.
• • 3. Urine protein ≥ 0.75g/24h or 24-hour urine protein creatinine ratio (PCR) ≥ 0.6 g/g.
• • 4. eGFR ≥ 25 ml/min/1.73 m2 calculated using the CKD-EPI formula.
• • 5. 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.
• • 6. Use of SGLT2, MRA, hydroxychloroquine, and etc. remained unchanged.
• • 7. Voluntarily participated in this study and signed the informed consent form.
• Exclusion Criteria:
• • 1. Patients with abnormal laboratory indicators (see study protocol for details).
• • 2. Secondary IgA nephropathy such as Henoch-Schonlein purpura, SLE, cirrhosis, etc.
• • 3. Use of systemic glucocorticoids/immunosuppressants within 3 months (such as cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, tripterygium wilfordii, etc.).
• • 4. Use of biological agents within 6 months (rituximab, etc.).
• • 5. 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.
• • 6. COVID-19 infection within 2 weeks before randomization.
• • 7. Live vaccine within 4 weeks before randomization.
• • 8. History of malignant tumor within five years.
• • 9. Uncontrolled hypertension (systolic blood pressure\>140mmHg or diastolic blood pressure\>90mmHg).
• • 10. Poorly controlled diabetes (glycosylated hemoglobin\>8%).
• • 11. Pregnant women and breastfeeding women.
• • 12. Participating in other clinical trials at the same time.
• • 13. Surgery, chemotherapy, radiotherapy and other treatments are planned during the study.
• • 14. Other reasons judged by researchers as unsuitable for inclusion in the study.