Actively Recruiting
A Prospective, Single-Arm Clinical Study of Budesonide in Combination With Ambrisentan for the Treatment of Patients With IgA Nephropathy
Led by The First Hospital of Jilin University · Updated on 2025-09-15
129
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Budesonide combined with Ambrisentan for treating patients with IgA nephropathy who have a risk of progressing to end-stage kidney disease (ESKD). This prospective, single-arm clinical trial aims to observe the effects of this combination on reducing urinary protein levels and slowing the decline of kidney function, as well as changes in serum Gd-IgA1 levels. The study is planned to include 129 patients diagnosed with primary IgA nephropathy. Participants who meet the screening criteria will receive Budesonide at a dose of 16 mg per day and Ambrisentan at 5 mg per day, both taken orally for 36 weeks. The study includes a screening period completed within 30 days before treatment begins and a total of six visits throughout the study. After the treatment period, data from all enrolled patients will be analyzed, and if results are promising, further randomized controlled trials may be conducted. During the study, participants will undergo multiple visits for medical history review, medication monitoring, and examination results collection to ensure eligibility and safety. Researchers will measure changes in 24-hour urinary protein, estimated glomerular filtration rate (eGFR), and serum levels of IgA, IgG, IgM, and Gd-IgA1 from enrollment through the 36-week treatment. The trial also monitors the annualized eGFR slope to assess kidney function progression over the study period.
CONDITIONS
Brief Title
Nefecon and Ambrisentan in IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with IgA nephropathy by pathological biopsy within 4 years
- Age between 18 and 70 years old
- 24-hour urinary protein of at least 0.5 grams
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m² calculated using the CKD-EPI formula
You will not qualify if you...
- Presence of special pathological or clinical kidney diseases such as crescentic glomerulonephritis (over 50%), or minimal change nephropathy with IgA deposition
- Secondary IgA nephropathy due to conditions like allergic purpura, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, viral hepatitis, cirrhosis, rheumatoid arthritis, or mixed connective tissue disease
- Cardiovascular events within the previous 12 weeks including myocardial infarction, unstable angina, ventricular arrhythmia, heart failure (NYHA class II or above), or stroke
- Systemic use of immunosuppressants or endothelin receptor antagonists within 12 weeks before first medication
- Active tuberculosis or untreated latent tuberculosis
- Active hepatitis or latent hepatitis B infection as per specified criteria
- History of immunodeficiency diseases or positive HIV test
- Diagnosis of malignant tumors within the past 5 years except certain treated skin or cervical cancers
- Undergoing kidney transplantation
- Pregnant or lactating women and individuals with fertility plans during the trial
- Allergy to human-derived biological products
- Use of any clinical trial medication within 4 weeks prior to first use
- Deemed unsuitable by researchers for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 30 days
Participants are screened for eligibility to participate in the trial.
Duration - 36 weeks
Participants are treated with Budesonide (Nefecon®) and Ambrisentan orally for IgA nephropathy.
6 visits including screening and treatment visits
Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
Research Team
W
Weixia Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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