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Clinical Trials in China / NCT06676007
Recruiting Observational

A Multi-center Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy

NCT06676007 · tracked via the Priya Life Science China tracker
Sponsor
Sichuan Provincial People's Hospital
Phase
Observational
Started
2024-10-30
Last updated
2026-01-15

Condition(s) studied

IgA Nephropathy (IgAN)Early Initial Therapy

Investigational drug(s) / intervention(s)

Gd-IgA1 test

Gd-IgA1 test: collect and test Gd-IgA1 test in enrolled subjects

Study summary

To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Target patients aged 18-75, including those aged 18 and 75 2. Primary IgA nephropathy diagnosed by renal biopsy within 3 months 3. eGFR≥30ml/min/1.73m2 4. 24-hour urine protein ≥ 1.0g/d, or UPCR ≥ 0.8 g/g 5. Sign informed consent Exclusion Criteria: 1. Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis 2. Patients who have received kidney transplantation or dialysis 3. Patients with other glomerular diseases (such as C3 glomerular disease and/or diabetes nephropathy) and nephrotic syndrome (i.e. proteinuria\>3.5 g/d, serum albumin\<3.0 g/dl, with or without edema) 4. Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections 5. Patients with type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c\>8%) 6. Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically significant arrhythmias 7. Patients with poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg) 8. Patients diagnosed with malignant tumors within the past 5 years 9. Patients with known glaucoma, known cataracts, and/or a history of cataract surgery 10. Gastrointestinal diseases that may interfere with the study of drug efficacy or release, such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea 11. Patients with severe adverse reactions to steroids in the past, including psychiatric symptoms 12. Patients who have received systemic immunosuppressive drug treatment within 3 months prior to enrollment 13. Patients who have received any systemic GCS treatment within the past 3 months prior to enrollment 14. Patients taking potent cytochrome P450 3A4 inhibitors (CYP3A4) 15. Current or previous (within the past 2 years) alcoholism or drug abuse; 16. Expected lifespan\<5 years 17. During the study treatment period and 3-month follow-up period, women who are pregnant, breastfeeding, or unwilling to use highly effective contraception (contraception is only required for women with fertility potential) 18. Researchers believe that patients who are not suitable for treatment with Nefecon

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sichuan Provincial People's Hospital Chengdu Sichuan Recruiting

More Sichuan Provincial People's Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06676007 on ClinicalTrials.gov ↗ ← All trials in China