New hope for kidney patients: early budesonide may slow IgA nephropathy
NCT ID NCT06676007
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether starting budesonide capsules early can help people with IgA nephropathy, a kidney disease. About 200 adults with recent diagnosis and high protein in urine will take the drug for 12 months. Researchers will measure changes in protein levels and kidney function to see if the treatment is safe and effective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Male or female, aged 18 to 75 years, diagnosed with primary IgA nephropathy through renal biopsy within 3 months, with eGFR ≥ 30ml/min/1.73m2, 24-hour urinary protein ≥ 1.0g/d, and blood pressure\<140/90mmHg
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sichuan Provincial People's Hospital
RECRUITINGChengdu, Sichuan, 610072, China
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Other studies related to the condition(s) this trial covers.
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- Can engineered immune cells tame autoimmune kidney disease?
- Can an Anti-Inflammatory diet protect the kidneys? a trial puts the autoimmune protocol to the test