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Budesonide Enteric Capsules in Combination with Immunosuppressive Agents for IgA Nephropathy: A Prospective Open Cohort Study

Budesonide Enteric Capsules in Combination with Immunosuppressive Agents for IgA Nephropathy: A Prospective Open Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500103064
Enrollment
Unknown
Registered
2025-05-23
Start date
2025-05-06
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

IgA nephropathy

Interventions

Budesonide enteric-coated capsules immunosuppressant (cyclophosphamide/mycophenolate mofetil) combination therapy group:None
Budesonide enteric-coated capsule treatment group:None

Sponsors

The First Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ??(1) Obtain written informed consent;?? ??(2) Aged 18-80 years;?? ??(3) Confirmed diagnosis of IgAN by renal pathological biopsy;?? ??(4) 24-hour proteinuria >1g or UACR >=800 mg/g;?? ??(5) 30 <= eGFR <= 90 mL/min/1.73m².?

Exclusion criteria

Exclusion criteria: ??(1) Kidney transplant recipients;?? ??(2) Patients with systemic diseases that may cause mesangial IgA deposition, including but not limited to Henoch-Schönlein purpura, systemic lupus erythematosus, dermatitis herpetiformis, and ankylosing spondylitis;?? ??(3) Patients with other glomerular diseases or concurrent nephrotic syndrome;?? ??(4) Patients with acute, chronic, or latent infectious diseases;?? ??(5) Patients with severe comorbid cardiac, hepatic, or pulmonary diseases;?? ??(6) Patients with hypersensitivity to study medications;?? ??(7) Patients with malignancies;?? ??(8) Patients with a history of significant upper gastrointestinal (GI) disorders, such as peptic ulcer disease, esophagitis, or severe dyspepsia;?? ??(9) Patients who are pregnant, lactating, or planning pregnancy;?? ??(10) Patients with psychiatric disorders or inability to adhere to follow-up;?? ??(11) Other conditions deemed unsuitable for study participation by investigators.??

Design outcomes

Primary

MeasureTime frame
Urine Albumin-to-Creatinine Ratio (UACR);24-hour urinary protein quantity;Serum Albumin;urine volume;

Secondary

MeasureTime frame
creatinine;estimated glomerular filtration rate;Cystatin C;

Countries

China

Contacts

Public ContactLijie He

The First Affiliated Hospital of Air Force Medical University

43218204@qq.com+86 150 9118 5737

Outcome results

None listed

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