Early targeted-release budesonide (Nefecon) for primary IgA nephropathy

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

This study will try starting targeted-release budesonide early in adults with recent primary IgA nephropathy to see if it lowers protein in the urine and is safe.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Provincial People's Hospital (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06676007 on ClinicalTrials.gov

What this trial studies

This is a prospective, open-label, multicenter observational effort testing early initiation of targeted-release budesonide (enteric-coated Nefecon) in adults with recently biopsy-proven primary IgA nephropathy. Eligible participants are adults 18–75 with eGFR ≥30 ml/min/1.73 m2 and proteinuria (≥1.0 g/day or UPCR ≥0.8 g/g) who will receive the therapy and be followed for efficacy and safety outcomes. The protocol includes measurement of proteinuria, renal function over time, adverse events, and Gd-IgA1 testing as a biomarker. Major exclusions include secondary IgAN, prior transplant or dialysis, nephrotic syndrome, uncontrolled diabetes, and active infections.

Who should consider this trial

Good fit: Adults aged 18–75 with a renal biopsy within the past 3 months confirming primary IgA nephropathy, eGFR ≥30 ml/min/1.73 m2, and proteinuria ≥1.0 g/day (or UPCR ≥0.8 g/g) who can give informed consent are ideal candidates.

Not a fit: Patients with secondary IgA disease, nephrotic-range proteinuria, advanced renal failure (eGFR <30), prior kidney transplant or ongoing dialysis, uncontrolled diabetes, or active infectious diseases are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If effective, early targeted-release budesonide could reduce proteinuria and help preserve kidney function while avoiding some systemic steroid side effects.

How similar studies have performed: Randomized trials of targeted-release budesonide (Nefecon) have previously shown reductions in proteinuria and suggested slower eGFR decline, so the approach has supporting clinical evidence though early-initiation in this exact subset is less extensively studied.

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

Where this trial is running

Chengdu, Sichuan

• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Guisen Li, Doctor

Conditions IgA Nephropathy; Early Initial Therapy; Nefecon; multi-center