RecruitingPhase 4NCT07030894

Nefecon and Ambrisentan in IgA Nephropathy

A Prospective, Single-Arm Clinical Study of Budesonide in Combination With Ambrisentan for the Treatment of Patients With IgA Nephropathy


Sponsor

The First Hospital of Jilin University

Enrollment

129 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Application of Budesonide in Combination with Ambrisentan in the treatment of IgA nephropathy with progression ESKD risk (24-hour urinary protein ≥ 0.5g/24h), observing the degree and safety of reducing urinary protein and delaying eGFR progression, and observing changes in serum Gd-IgA1 levels


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — nefecon (a targeted gut-released steroid) and ambrisentan (a drug that widens blood vessels) — for people with IgA nephropathy, a kidney disease caused by immune deposits that damage the kidneys over time. **You may be eligible if:** - You are between 18 and 70 years old - You have been diagnosed with IgA nephropathy by kidney biopsy within the past 4 years - You have significant protein in your urine (at least 0.5 g per 24 hours) - Your kidney filtration rate (eGFR) is at least 30 mL/min/1.73 m² **You may NOT be eligible if:** - Your biopsy shows special subtypes of kidney disease that look similar to IgA nephropathy but are a different condition - You have secondary IgA nephropathy caused by another disease (such as lupus, hepatitis, or rheumatoid arthritis) - You are pregnant or breastfeeding - You have severe kidney disease or uncontrolled blood pressure 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

DRUG"Nefecon®","Ambrisentan"

Subjects who meet the screening criteria will be treated with Budesonide in combination with Ambrisentan. Budesonide (Nefecon®), 16mg/d for 36 weeks, taken orally. Ambrisentan , 5mg/d for 36 weeks, taken orally.


Locations(1)

The First Hospital of Jilin University

Changchun, Jilin, China

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NCT07030894


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