IgA NephropathyPhase 4BAINNCT07030894
Nefecon and Ambrisentan in IgA Nephropathy
A Phase 4 study testing "Nefecon®","Ambrisentan" in people with IgA Nephropathy and Chronic Kidney Disease, run by The First Hospital of Jilin University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IgA Nephropathy, Chronic Kidney Disease, Proteinuria
- What is being tested?
- "Nefecon®","Ambrisentan"
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ㎡
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Weixia Sun, M.D., 15804300380, sunwx@jlu.edu.cn
Yi Yang, M.M., 15048136878, 15048136878@163.com
About this study
Official title: A Prospective, Single-Arm Clinical Study of Budesonide in Combination With Ambrisentan for the Treatment of Patients With IgA Nephropathy
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
Read the detailed description
This study is a prospective, single arm clinical trial planned to recruit 129 patients with primary IgA nephropathy. Including a screening period and a treatment period, a total of 6 visits were conducted. The screening period was completed within 30 days before the treatment period, and the medical history, medication, and examination results collected during the visits were used as the basis for screening subjects in this study. Subjects who met the inclusion criteria but did not meet any exclusion criteria were enrolled in the study and treated with Budesonide in combination with Ambrisentan for a total of 36 weeks. After the end of the trial, data from 129 enrolled patients were analyzed for statistical analysis. If the treatment is effective, randomized controlled trials will be added to validate it when conditions permit.
- Conditions
- IgA Nephropathy, Chronic Kidney Disease, Proteinuria
- Being tested
- "Nefecon®","Ambrisentan"
- Keywords
- Proteinuria, IgA Nephropathy, Budesonide, Ambrisentan, Single-arm trial
- Medical subject headings
- Glomerulonephritis, IGA, Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Nefecon®","Ambrisentan"Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy | Experimental | Subjects who meet the screening criteria will be treated with Budesonide in combination with Ambrisentan. Budesonide , 16mg/d for 36 weeks, taken orally. Ambrisentan , 5mg/d for 36 weeks, taken orally. Receives: Drug: "Nefecon®","Ambrisentan" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in UPCR (24h urine)
Measured: From enrollment to the end of treatment at 36 weeks
Secondary outcomes (3)
Change in eGFR
Measured: From enrollment to the end of treatment at 36 weeks
Changes in IgA/IgG/IgM and Gd-IgA1 levels at all visits
Measured: From enrollment to the end of treatment at 36 weeks
Annualized eGFR slope at Week 36
Measured: From enrollment to the end of treatment at 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030894
- Sponsor's protocol ID
- 25K183-001
- Acronym
- BAIN
- Status last verified
- Aug 2025
- First submitted
- 8 Jun 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Clinical Study of Budesonide in Combination With Ambrisentan for the Treatment of Patients With IgA Nephropathy
- ClinicalTrials.gov ID
- NCT07030894
- Acronym / sponsor ID
- BAIN / 25K183-001
- Conditions
- IgA Nephropathy, Chronic Kidney Disease, Proteinuria
- Keywords
- Proteinuria, IgA Nephropathy, Budesonide, Ambrisentan, Single-arm trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study is a prospective, single arm clinical trial planned to recruit 129 patients with primary IgA nephropathy. Including a screening period and a treatment period, a total of 6 visits were conducted. The screening period was completed within 30 days before the treatment period, and the medical history, medication, and examination results collected during the visits were used as the basis for screening subjects in this study. Subjects who met the inclusion criteria but did not meet any exclusion criteria were enrolled in the study and treated with Budesonide in combination with Ambrisentan for a total of 36 weeks. After the end of the trial, data from 129 enrolled patients were analyzed for statistical analysis. If the treatment is effective, randomized controlled trials will be added to validate it when conditions permit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination therapy | Experimental | Drug: "Nefecon®","Ambrisentan"Subjects who meet the screening criteria will be treated with Budesonide in combination with Ambrisentan. Budesonide , 16mg/d for 36 weeks, taken orally. Ambrisentan , 5mg/d for 36 weeks, taken orally. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 ㎡
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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. | Drug | Combination therapy |
Primary outcome
Percent change in UPCR (24h urine)
Time frame: From enrollment to the end of treatment at 36 weeks
3 secondary outcomes
Change in eGFR
Time frame: From enrollment to the end of treatment at 36 weeks
Changes in IgA/IgG/IgM and Gd-IgA1 levels at all visits
Time frame: From enrollment to the end of treatment at 36 weeks
Annualized eGFR slope at Week 36
Time frame: From enrollment to the end of treatment at 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing "Nefecon®","Ambrisentan" in people with IgA Nephropathy and Chronic Kidney Disease, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weixia Sun (+8615804300380, sunwx@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in UPCR (24h urine) (time frame: From enrollment to the end of treatment at 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.