Nefecon (budesonide) plus ambrisentan for IgA nephropathy with proteinuria

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

This test will see if combining Nefecon (a gut‑targeted budesonide) with ambrisentan can reduce urine protein and slow kidney decline in adults with IgA nephropathy who have at least 0.5 g of protein in a 24‑hour urine collection.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 129 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Drugs / interventions: rituximab, cyclophosphamide
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT07030894 on ClinicalTrials.gov

What this trial studies

This is a prospective, single‑arm Phase 4 trial enrolling 129 adults with biopsy‑proven primary IgA nephropathy, proteinuria ≥0.5 g/24h, and eGFR ≥30 mL/min/1.73 m2. After a screening period, participants receive combined Nefecon (budesonide) and ambrisentan treatment for 36 weeks with a total of six study visits for clinical and laboratory monitoring. Primary observations include the degree and safety of urinary protein reduction, changes in eGFR trajectory, and serum galactose‑deficient IgA1 (Gd‑IgA1) levels. If signals of benefit are seen, randomized controlled trials are planned when feasible to validate the findings.

Who should consider this trial

Good fit: Adults aged 18–70 with biopsy‑confirmed primary IgA nephropathy within the past four years, 24‑hour urine protein ≥0.5 g, and eGFR ≥30 mL/min/1.73 m2 are the intended participants.

Not a fit: Patients with secondary causes of IgA deposition, certain special pathological kidney types (e.g., >50% crescentic glomerulonephritis), recent major cardiovascular events, or eGFR <30 are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could lower proteinuria and help delay progression of kidney function decline in patients with IgA nephropathy.

How similar studies have performed: Targeted budesonide (Nefecon) has reduced proteinuria in prior randomized trials, but combining it with ambrisentan is a novel approach that has not been validated in large randomized studies.

Eligibility criteria

Inclusion Criteria:

* Diagnosed with IgA nephropathy by pathological biopsy within 4 years;
* Age between 18 and 70 years old;
* 0.5g/24h ≤ 24-hour urinary protein;
* The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula satisfies: eGFR ≥ 30 mL/min/1.73 ㎡

Exclusion Criteria:

* Exclude special pathological or clinical kidney disease types such as crescentic glomerulonephritis (pathological diagnosis\>50%), minimal change nephropathy with IgA deposition, etc;
* Exclude secondary IgA nephropathy, including allergic purpura, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, viral hepatitis, cirrhosis, rheumatoid arthritis, and mixed connective tissue disease;
* Select patients who have experienced any of the following cardiovascular events within the previous 12 weeks: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association class II or above heart failure, stroke, etc;
* Within 12 weeks prior to the first medication, systemic use (excluding local and nasal inhalation use) of immunosuppressants, including but not limited to glucocorticoids, cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, rituximab, Tripterygium wilfordii, etc; Have used an endothelin receptor antagonist within 12 weeks prior to the first medication;
* Active tuberculosis patients and untreated latent tuberculosis patients;
* Patients with active hepatitis or latent hepatitis B (patients with HBcAb positive and HBV DNA positive); According to the results of the five hepatitis B tests, patients with HBsAg positivity should be excluded; Patients who are HBsAg negative but HBcAb positive, regardless of whether HBsAb is positive or negative, need to be tested for HBV-DNA to determine their condition: if HBV-DNA is positive, the patient needs to be excluded; If HBV-DNA is negative, patients can participate in the trial;
* History of immunodeficiency diseases or positive HIV test results (enzyme-linked immunosorbent assay and protein immunoblotting);
* Patients diagnosed with malignant tumors within the past 5 years, except for treated basal cell carcinoma of the skin, effectively resected squamous cell carcinoma of the skin, colon polyps, or cervical cancer in situ;
* Patients undergoing kidney transplantation;
* Pregnant women, lactating women, and men or women with fertility plans during the trial period;
* For individuals allergic to human derived biological products;
* Patients who have received any clinical trial medication within 4 weeks prior to their first use;
* Participants deemed unsuitable by researchers.

Where this trial is running

Changchun, Jilin

• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: Weixia Sun

Conditions IgA Nephropathy; Chronic Kidney Disease; Proteinuria; Budesonide; Ambrisentan; Single-arm trial