New combo therapy aims to shield kidneys in IgA disease
NCT ID NCT07585981
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding budesonide capsules early to standard blood-pressure and sugar-lowering drugs can reduce protein in the urine of people with IgA nephropathy, a kidney disease. Thirty adults with newly diagnosed disease will take the combination for 9 months, then taper off budesonide while continuing the other drugs. The main goal is to see if proteinuria drops after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- budesonide (Nefecon) enteric-coated capsules
- What this could lead to
- If successful, this could show that adding budesonide early helps control kidney damage and reduces protein leakage in IgA nephropathy patients.
- What could go wrong
- This is a small, early-phase study with only 30 participants and no placebo group, so results may not be conclusive or apply to all patients. Budesonide can cause side effects like steroid-related issues.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Oct 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
Age ≥ 18 years，primary IgA nephropathy confirmed by renal-biopsy pathology within the past 2 weeks，eGFR ≥ 20 mL/min/1.73 m²，24-hour urinary protein 0.5-3.5 g/day，patient has been fully informed, agrees to receive supportive care plus budesonide enteric-coated capsules, and has signed the informed-consent form
- Ages
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18 years and older
- 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) Age ≥ 18 years (2) Primary IgA nephropathy confirmed by renal-biopsy pathology within the past 2 weeks (3) eGFR ≥ 20 mL/min/1.73 m² (4) 24-hour urinary protein 0.5-3.5 g/day (5) Patient has been fully informed, agrees to receive supportive care plus budesonide enteric-coated capsules, and has signed the informed-consent form Exclusion Criteria: * (1) Secondary IgAN attributable to, but not limited to, Henoch-Schönlein purpura, systemic lupus erythematosus, liver cirrhosis, rheumatoid arthritis, or ankylosing spondylitis (2) Previous renal transplantation or current dialysis (3) Co-existing glomerular disease on biopsy (e.g., C3 glomerulopathy, diabetic nephropathy) or nephrotic syndrome (4) Acute, chronic, or latent infection, including hepatitis, tuberculosis, HIV, or chronic urinary-tract infection (5) Type 1 or type 2 diabetes with poor control (HbA1c \> 9 %) (6) History of unstable angina, NYHA class III/IV congestive heart failure, or clinically significant arrhythmia (7) Uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥ 90 mmHg) (8) Malignancy diagnosed within the past 5 years (9) Known glaucoma, cataract, or history of cataract surgery (10) Gastro-intestinal disorders that may interfere with drug release or efficacy (peptic-ulcer disease, inflammatory bowel disease, chronic diarrhea) (11) Previous severe adverse reaction to corticosteroids, including psychotic symptoms (12) Concomitant use of potent cytochrome P450 3A4 (CYP3A4) inhibitors (13) Pregnancy, lactation, or unwillingness to use highly effective contraception during treatment and the 3-month follow-up (applies to women of child-bearing potential) (14) Patients whom the investigator deems unsuitable for budesonide enteric-coated-capsule therapy
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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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Chinese PLA General Hospital
RECRUITINGBeijing, China