IgA nephropathy
Conditions
Interventions
Test group:Optimize the support treatment by administering budesonide nasal spray. Treatment period (total of 12 weeks): First 8 weeks: twice daily, one spray per nostril each time
Last 4 weeks: once every other day, one spray per nostril each time
Follow-up period: 12 weeks. Optimized support treatment includes lifestyle interventions, RAASi±SGLT2i, blood pressure management, etc.
Sponsors
The First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18-70 years old; 2. Pathological diagnosis of primary IgAN, eGFR=30mL/min/1.73 m2; 3. 24-hour urinary protein quantification >0.75g and <3.5g at the time of diagnosis; 4. A clear history of recurrent tonsillitis or pharyngitis; and after sufficient anti-infection treatment, the tonsils still tend to repeatedly inflame and swell more than twice; 5. Non-pregnant women with a negative urine pregnancy test and willing to have no pregnancy plans for the next 18 months and take effective contraceptive measures; 6. First treatment after diagnosis, with no previous treatment history; 7. Agree to participate in this project and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Expected survival time of <3 months for malignant tumors and other diseases; 2. Severe cardiovascular or cerebrovascular disease; 3. Respiratory tract infection (including fungal, viral infections) within the past 2 weeks that has not been cured; 4. Complicated with diabetes or other autoimmune diseases; 5. Unhealed oral/nasopharyngeal ulcers; 6. Infected with HIV or other serious infectious diseases; 7. Psychiatric disorders or intellectual disabilities; 8. History of alcohol/drug abuse; 9. Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 24-hour urinary protein quantification or UPCR from baseline after 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in 24-hour urinary protein quantification or UPCR from baseline at 12 weeks follow-up;Change in eGFR slope at 12 weeks of treatment and 12 weeks of follow-up;Change in serum albumin at 12 weeks of treatment and 12 weeks of follow-up;Change in urinary red blood cell count from baseline at 12 weeks of treatment and 12 weeks of follow-up;Changes from baseline at 12 weeks of treatment and 12 weeks of follow-up (Gd-IgA1, BAFF, APRIL);Adverse events during treatment and follow-up (discomfort reported by participants and abnormal laboratory test indicators); | — |
Countries
China
Contacts
Public ContactShiren Sun; Zhao Jin
The First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed