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

NCT ID: NCT06676007

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-30
• Study Completion Date: 2027-06-30

Brief Summary

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

Conditions

IgA Nephropathy (IgAN); Early Initial Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Gd-IgA1 test

collect and test Gd-IgA1 test in enrolled subjects

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guisen Li

Director of Nephrology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guisen Li, Doctor

Role: CONTACT

guisenli@163.com

+86-28-87393340

Other Identifiers

NEF-EM-004

Identifier Type: -

Identifier Source: org_study_id