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The effectiveness of Nefecon in treating IgA nephropathy and its impact on intestinal IgA class switching

The effectiveness of Nefecon in treating IgA nephropathy and its impact on intestinal IgA class switching

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118965
Enrollment
Unknown
Registered
2026-02-13
Start date
2025-10-23
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

primary IgA nephropathy

Interventions

Observation group:None

Sponsors

Xiangya Second Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Primary IgA nephropathy confirmed by renal biopsy; 2.Age >= 18 years old; 3. 24-hour urinary protein quantification>0.5g/d; 4. Estimated glomerular filtration rate (eGFR)>30ml/min/1.73m^2 5. The patient or guardian voluntarily signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Systemic diseases that may lead to the deposition of mesangial immunoglobulin A (IgA), including but not limited to allergic purpura, systemic lupus erythematosus, herpetic dermatitis, ankylosing spondylitis, etc. 2. Combined with other kidney diseases, such as diabetes nephropathy, C3 glomerular disease, nephrotic syndrome, etc; 3. Active infection, severe liver dysfunction (Child Pugh C grade), congestive heart failure, and malignant tumors other than basal cell carcinoma within 5 years; 4. Allergic reactions to any ingredient in budesonide or budesonide enteric coated capsules, including severe hypersensitivity reactions, including allergic reactions, that have occurred with the use of other budesonide formulations; 5.Within the first 4 weeks of treatment with Dexmedetomidine enteric coated capsules, systemic hormone therapy (prednisone, methylprednisolone, etc.), immunosuppressive therapy (cyclophosphamide, cyclosporine, azathioprine, mycophenolic acid, calcineurin inhibitors, etc.), and biologic therapy targeting B cells (tacrolizumab, etc.) should be used; 6.Pregnant and lactating female patients.

Design outcomes

Primary

MeasureTime frame
The proportion of decreased AID and I a - C a levels compared to baseline in the 9th month;

Secondary

MeasureTime frame
The proportion of decreased levels of fecal IgA and Gd-IgA1 compared to baseline at each visit point;

Countries

China

Contacts

Public ContactLiu Hong

Xiangya Second Hospital of Central South University

liuh0618@163.com+86 139 7311 6951

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026