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Efficacy and safety of Nefecon in combination with low-dose corticosteroids in patients with primary IgA nephropathy at high risk of progression

A real-world study on the renal protection of budesonide sustained-release capsules in IgA nephropathy with high progression risk

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103994
Enrollment
Unknown
Registered
2025-06-10
Start date
2025-06-16
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

IgA nephropathy

Interventions

Intervention group:Low-dose corticosteroids combined with Nefecon

Sponsors

General Hospital of Ningxia Medical 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. 24h UTP>1.0g; 4. Estimated glomerular filtration rate (eGFR) >30ml/min/1.73m^2; 5. The patient or guardian voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with secondary IgA nephropathy; 2. Combined with severe liver impairment (Child-Pugh grade C), congestive heart failure and malignant tumors; 3. Allergy to budesonide or any of the ingredients in budesonide enteric-coated capsules; 4. Budesonide enteric-coated capsule treatment within 12 weeks before treatment, including but not limited to systemic hormonal therapy (prednisone, methylprednisolone, etc.), immunosuppressive therapy: cyclophosphamide, cyclosporine, azathioprine, mycophenolic acid, calcineurin inhibitors, etc., biologics targeting B cells: tetanercept, etc.; Pregnant and lactating females. 5. Uncontrolled diabetes mellitus and glycosylated hemoglobin (HbA1c) >8.5%; 6. Hepatitis B (hepatitis surface antigen positive or core antibody with surface antibody negative) or hepatitis C virus infection (HCV antibody positive); 7. Active systemic bacterial, viral, or fungal infection within 14 days prior to enrollment; 8. Nephrotic syndrome.

Design outcomes

Primary

MeasureTime frame
Urine protein-to-creatinine ratio;

Secondary

MeasureTime frame
Estimated Glomerular Filtration Rate;B cell activating factor;A proliferation inducing ligand;Galactose-deficient IgA1;

Countries

China

Contacts

Public ContactXiaoling Zhou

General Hospital of Ningxia Medical University

zxlingsky@163.com+86 138 9507 8577

Outcome results

None listed

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