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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sichuan Provincial People's Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Guisen Li, Doctor
• Email: guisenli@163.com
• Phone: +86-28-87393340

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JADE101 in IgA Nephropathy (phase 3, blinded)

  This phase 3 study tests whether JADE101 helps adults with IgA nephropathy more than a placebo.

  Recruiting at 4 sites Phase 3 Jade Biosciences, Inc. · Arvada, Colorado and 3 other locations · NCT07902817

• Personalized IgA Nephropathy treatment guided by Gd-IgA1 monitoring

  This study tests whether regularly checking a biomarker called Gd-IgA1 to guide treatment with Nefecon or telitacicept helps people with IgA nephropathy or related nephritis respond better.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07822100

• Long-term safety and effectiveness of HSK39297 tablets in IgA nephropathy patients who completed prior study

  This phase 2 trial tests whether taking HSK39297 once daily for IgA nephropathy is safe over the long term and helps reduce protein in the urine for patients who completed a previous study and meet criteria.

  Recruiting Phase 2 Haisco Pharmaceutical Group Co., Ltd. · Beijing and 1 other locations · NCT07616700

• Everest001: a medicine for certain kidney diseases to see if it helps adults

  This study tests EVER001 in adults with FSGS, MCD, or IgA nephropathy to see if it can help reduce protein in the urine and improve kidney function.

  Recruiting at 2 sites Phase 2 Everest Medicines (China) Co.,Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07614477

• Nefecon as a maintenance therapy to prevent relapse in IgA nephropathy

  This study tests whether continuing Nefecon after initial remission can lower the chance of relapse in adults with IgA nephropathy.

  Recruiting Phase 4 Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong · NCT07604311

• CD19/BCMA UCART for B cell–related autoimmune diseases

  This early-stage study tests QT-219CX, a universal allogeneic CAR-T cell therapy that targets CD19 and BCMA, in people with refractory B-cell–related autoimmune diseases to see if it can be given safely and provide early signs of benefit.

  Recruiting Early Phase 1 The Children's Hospital of Zhejiang University School of Medicine · Hangzhou, Zhejiang · NCT07586267

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.