NCT07585981Recruiting
Early Application of Budesonide Enteric-coated Capsules in the Treatment of Primary IgA Nephropathy.
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
This multicenter, open-label, prospective single-arm study will enroll adults (≥18 y) with primary IgA nephropathy confirmed by renal biopsy within 2 weeks, eGFR ≥20 ml/min/1.73 m² and 0.5-3.5 g/d proteinuria, to receive early (real-world) combination therapy with RASI (titrated irbesartan), SGLT2i (dapagliflozin 10 mg qd) and budesonide enteric-coated capsules (16 mg qd) for 9 months, followed by budesonide taper-off and continuation of RASI+SGLT2i for 3 more months (12 months total), with primary endpoint being change in proteinuria from baseline to month 12 and secondary endpoints changes in eGFR and microscopic hematuria.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 8 May 2026
- Start date
- 20 Oct 2025
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- Chinese PLA General Hospital
- Diseases
- IgA nephropathy
- NCT number
- NCT07585981
What you commit to
- Study type: Observational
- Planned participants: 30
- From 20 Oct 2025 to the primary completion date, 1 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- (1) Secondary IgAN attributable to, but not limited to, Henoch-Schönlein purpura, systemic lupus erythematosus, liver cirrhosis, rheumatoid arthritis, or ankylosing spondylitis (2) Previous renal transplantation or current dialysis (3) Co-existing glomerular disease on biopsy (e.g., C3 glomerulopathy, diabetic nephropathy) or nephrotic syndrome (4) Acute, chronic, or latent infection, including hepatitis, tuberculosis, HIV, or chronic urinary-tract infection (5) Type 1 or type 2 diabetes with poor control (HbA1c \> 9 %) (6) History of unstable angina, NYHA class III/IV congestive heart failure, or clinically significant arrhythmia (7) Uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥ 90 mmHg) (8) Malignancy diagnosed within the past 5 years (9) Known glaucoma, cataract, or history of cataract surgery (10) Gastro-intestinal disorders that may interfere with drug release or efficacy (peptic-ulcer disease, inflammatory bowel disease, chronic diarrhea) (11) Previous severe adverse reaction to corticosteroids, including psychotic symptoms (12) Concomitant use of potent cytochrome P450 3A4 (CYP3A4) inhibitors (13) Pregnancy, lactation, or unwillingness to use highly effective contraception during treatment and the 3-month follow-up (applies to women of child-bearing potential) (14) Patients whom the investigator deems unsuitable for budesonide enteric-coated-capsule therapy
Who the study is looking for
- (1) Age ≥ 18 years (2) Primary IgA nephropathy confirmed by renal-biopsy pathology within the past 2 weeks (3) eGFR ≥ 20 mL/min/1.73 m² (4) 24-hour urinary protein 0.5-3.5 g/day (5) Patient has been fully informed, agrees to receive supportive care plus budesonide enteric-coated capsules, and has signed the informed-consent form
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.