IgA Nephropathy
Conditions
Interventions
Glucocorticoid Monotherapy Group:None
Corticosteroid Sequential Telitacicept Regimen Group:None
Telitacicept Monotherapy Group:None
Sponsors
The 2nd Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, irrespective of gender; 2. Diagnosis of IgA nephropathy (IgAN) confirmed by renal biopsy; 3. 24-hour urinary protein >= 0.5 g or urinary protein-to-creatinine ratio (UPCR) >= 0.44 g/g; 4. Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m^2; 5. Planned to receive one of the following three therapeutic regimens: corticosteroid monotherapy, telitacicept monotherapy, or corticosteroid followed by telitacicept sequential therapy; 6. Ability to comply with the study procedures, and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with secondary IgAN; 2. Concurrent other chronic kidney diseases, such as diabetic kidney disease or membranous nephropathy; 3. Any specific pathological or clinical type of nephropathy, including nephrotic syndrome, crescentic glomerulonephritis (involving >50% of glomeruli on biopsy), or IgAN with minimal change disease; 4. Use of corticosteroids, immunosuppressants, biological agents, or traditional Chinese medicines containing immunosuppressive components within 24 weeks prior to screening; 5. Presence of severe or active infections, malignant tumors, autoimmune diseases, hepatic dysfunction, heart failure, myocardial infarction, stroke, or other significant comorbidities; 6. Lack of essential baseline data; 7. History of psychiatric illness or other conditions that may impair cooperation; 8. Prior or planned renal or other organ transplantation during the study period; 9. Pregnant or lactating women, or women planning to become pregnant; 10. Any other condition that, in the investigator’s judgment, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 24-hour urinary protein from baseline at 36 weeks of follow-up; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and serious adverse events during the follow-up period;Change in urinary red blood cell count from baseline at each study visit;Cumulative dose of corticosteroids used during the follow-up period;Change in 24-hour urinary protein from baseline at all other study visits;Incidence of the composite kidney outcome during follow-up, defined as a =40% decline in eGFR from baseline or progression to ESKD;Change in eGFR from baseline at each study visit;Incidence of all-cause mortality during the follow-up period;Changes in serum proteomic and metabolomic profiles at Week 24;Proportion of patients achieving 24-hour urinary protein =40% decline in eGFR from baseline during the follow-up period;Proportion of patients achieving a sustained =50% reduction in 24-hour urinary protein or UPCR from baseline at each study visit; | — |
Countries
China
Contacts
Public ContactLiao Xiaohui
The 2nd Affiliated Hospital of Chongqing Medical University
Outcome results
None listed