RecruitingNCT06676007

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

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


Sponsor

Sichuan Provincial People's Hospital

Enrollment

200 participants

Start Date

Oct 30, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted-release form of budesonide — a steroid that acts directly in the gut — as an early treatment for IgA nephropathy, a kidney disease caused by a faulty immune protein building up in the kidneys. The goal is to see if starting this drug early can better protect kidney function. **You may be eligible if...** - You are 18–75 years old - You were recently diagnosed with primary IgA nephropathy confirmed by kidney biopsy (within the last 3 months) - Your kidneys still have reasonable function (eGFR ≥30) - You have significant protein leaking into your urine **You may NOT be eligible if...** - You have secondary IgA nephropathy (caused by another disease like liver disease or lupus) - You are already taking or have recently taken certain steroids or immunosuppressants - You have severe kidney damage or other major organ problems - You are pregnant or breastfeeding - You are allergic to budesonide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERGd-IgA1 test

collect and test Gd-IgA1 test in enrolled subjects


Locations(1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

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NCT06676007


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