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Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy with Unsatisfactory Response to Traditional Therapy

Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy with Unsatisfactory Response to Traditional Therapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064790
Enrollment
Unknown
Registered
2022-10-18
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA Nephropathy

Interventions

Sponsors

Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18~65, regardless of gender; 2. Primary IgAN has been confirmed by renal puncture biopsy; 3. 24h urine protein >= 1g/24h after 3 months of treatment with glucocorticoids combined with or without immunosuppressive agents and with or without ACEI/ARB; 4. eGFR>30mL/min /1.73m^2 5. Volunteers to participate in this study after signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Secondary IgA nephropathy, such as IgA vasculitis, viruses (HIV, hepatitis)infections, inflammatory bowel disease, autoimmune diseases, cirrhosis and other infectious factors; 2. Patients with severe chronic pathological changes: glomerulosclerosis or interstitial fibrosis>50%; 3. In the past 6 months, biological agents have been used for treatment, such as CD20 monoclonal antibody, belizumab, etc; 4. Patients newly receiving immunosuppressive therapy within 4 weeks before the start of the study; 5. Persons allergic to the study drugs; 6. Women during pregnancy or breastfeeding or preparing for pregnangy; 7. Patients with malignant tumors; 8. Patients who received surgical treatment within 4 weeks before the start of the study; 9. Subjects participating in other clinical trials; 10.In addition to the above, other circumstances that the researchers consider unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Incidence of deterioration of renal function;

Secondary

MeasureTime frame
24h urine protein;eGFR;Urine protein creatinine ratio(UPCR);serum creatinine;serum IgA;serum IgG;serum IgM;

Countries

China

Contacts

Public ContactSun Jing

Shandong Provincial Hospital

sddialysis@126.com+86 15168886367

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026