NCT06654596 Efficacy and Safety of Telitacicept in IgAN
| NCT ID | NCT06654596 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | IgA Nephropathy (IgAN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2024-12-06 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 118 participants in total. It began in 2024-12-06 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06654596 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying IgA Nephropathy (IgAN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06654596 currently recruiting?
Yes, NCT06654596 is actively recruiting participants. Contact the research team at nephroxie@163.com for enrollment information.
Where is the NCT06654596 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06654596 clinical trial?
NCT06654596 is sponsored by Ruijin Hospital. The trial plans to enroll 118 participants.