IgA Nephropathy (IgAN)NCT06676007
A Multi-center Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy
An observational study of IgA Nephropathy (IgAN) and Early Initial Therapy, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IgA Nephropathy (IgAN), Early Initial Therapy
- What is being tested?
- Gd-IgA1 test
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 30 Jun 2027
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female, aged 18 to 75 years, diagnosed with primary IgA nephropathy through renal biopsy within 3 months, with eGFR ≥ 30ml/min/1.73m2, 24-hour urinary protein ≥ 1.0g/d, and blood pressure<140/90mmHg
Who may be able to join
- Target patients aged 18-75, including those aged 18 and 75
- Primary IgA nephropathy diagnosed by renal biopsy within 3 months
- eGFR≥30ml/min/1.73m2
- 24-hour urine protein ≥ 1.0g/d, or UPCR ≥ 0.8 g/g
- Sign informed consent
Who cannot join
- Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis
- Patients who have received kidney transplantation or dialysis
- Patients with other glomerular diseases (such as C3 glomerular disease and/or diabetes nephropathy) and nephrotic syndrome (i.e. proteinuria>3.5 g/d, serum albumin<3.0 g/dl, with or without edema)
- Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections
- Patients with type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c>8%)
- Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically significant arrhythmias
Show all 18Show fewer
- Patients with poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg)
- Patients diagnosed with malignant tumors within the past 5 years
- Patients with known glaucoma, known cataracts, and/or a history of cataract surgery
- Gastrointestinal diseases that may interfere with the study of drug efficacy or release, such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea
- Patients with severe adverse reactions to steroids in the past, including psychiatric symptoms
- Patients who have received systemic immunosuppressive drug treatment within 3 months prior to enrollment
- Patients who have received any systemic GCS treatment within the past 3 months prior to enrollment
- Patients taking potent cytochrome P450 3A4 inhibitors (CYP3A4)
- Current or previous (within the past 2 years) alcoholism or drug abuse;
- Expected lifespan<5 years
- During the study treatment period and 3-month follow-up period, women who are pregnant, breastfeeding, or unwilling to use highly effective contraception (contraception is only required for women with fertility potential)
- Researchers believe that patients who are not suitable for treatment with Nefecon
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
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
About this study
Official title: A Multicenter Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy
To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.
- Conditions
- IgA Nephropathy (IgAN), Early Initial Therapy
- Being tested
- Gd-IgA1 test
- Keywords
- IgA Nephropathy (IgAN), Nefecon, multi-center, Early Initial Therapy
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gd-IgA1 testOther
collect and test Gd-IgA1 test in enrolled subjects
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in proteinuria levels
To evaluate the changes in proteinuria levels of the target patient in the 12th month compared to baseline
Measured: about 12 months
Number of Participants With clinical significant Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Safety event
Measured: about 12 months
Secondary outcomes (7)
Evaluate the changes in eGFR of target patients at the 12th month compared to baseline
Measured: about 12 months
Evaluate the changes in microscopic hematuria of the target patient at the 12th month compared to baseline
Measured: about 12 months
Assess the incidence of composite renal endpoint events (eGFR decreased by 40% from baseline or ESKD) in target patients
Measured: about 12 months
Assess the incidence of ESKD (eGFR<15ml/min/1.73m2) in target patients at the 12th month
Measured: about 12 months
Evaluate the proportion of target patients with a 40% decrease in eGFR compared to baseline at the 12th month
Measured: about 12 months
Evaluate the proportion of target patients whose average urinary protein level decreased by 50% from baseline in the 12th month
Measured: about 12 months
Evaluate the changes in serum and urine proteomics and metabolomics of the target patient in the 12th month
Measured: about 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start30 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guisen Li, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676007
- Sponsor's protocol ID
- NEF-EM-004
- Status last verified
- Jan 2026
- First submitted
- 31 Oct 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy
- ClinicalTrials.gov ID
- NCT06676007
- Acronym / sponsor ID
- NEF-EM-004
- Conditions
- IgA Nephropathy (IgAN), Early Initial Therapy
- Keywords
- IgA Nephropathy (IgAN), Nefecon, multi-center, Early Initial Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Nov 2024 (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.
To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female, aged 18 to 75 years, diagnosed with primary IgA nephropathy through renal biopsy within 3 months, with eGFR ≥ 30ml/min/1.73m2, 24-hour urinary protein ≥ 1.0g/d, and blood pressure<140/90mmHg
Key inclusion criteria (5 listed)
- Target patients aged 18-75, including those aged 18 and 75
- Primary IgA nephropathy diagnosed by renal biopsy within 3 months
- eGFR≥30ml/min/1.73m2
- 24-hour urine protein ≥ 1.0g/d, or UPCR ≥ 0.8 g/g
- Sign informed consent
Key exclusion criteria (18 listed)
- Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis
- Patients who have received kidney transplantation or dialysis
- Patients with other glomerular diseases (such as C3 glomerular disease and/or diabetes nephropathy) and nephrotic syndrome (i.e. proteinuria>3.5 g/d, serum albumin<3.0 g/dl, with or without edema)
- Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections
- Patients with type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c>8%)
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 |
|---|---|---|
| Gd-IgA1 testcollect and test Gd-IgA1 test in enrolled subjects | Other | – |
Primary outcome
The changes in proteinuria levels
Time frame: about 12 months
To evaluate the changes in proteinuria levels of the target patient in the 12th month compared to baseline
Number of Participants With clinical significant Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Time frame: about 12 months
Safety event
7 secondary outcomes
Evaluate the changes in eGFR of target patients at the 12th month compared to baseline
Time frame: about 12 months
Evaluate the changes in microscopic hematuria of the target patient at the 12th month compared to baseline
Time frame: about 12 months
Assess the incidence of composite renal endpoint events (eGFR decreased by 40% from baseline or ESKD) in target patients
Time frame: about 12 months
Assess the incidence of ESKD (eGFR<15ml/min/1.73m2) in target patients at the 12th month
Time frame: about 12 months
Evaluate the proportion of target patients with a 40% decrease in eGFR compared to baseline at the 12th month
Time frame: about 12 months
Evaluate the proportion of target patients whose average urinary protein level decreased by 50% from baseline in the 12th month
Time frame: about 12 months
Evaluate the changes in serum and urine proteomics and metabolomics of the target patient in the 12th month
Time frame: about 12 months
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 Jan 2026.
- Individual participant dataSharing planned: No
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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?
An observational study of IgA Nephropathy (IgAN) and Early Initial Therapy, run by Sichuan Provincial People's Hospital 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 5 inclusion and 18 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 Jan 2026. 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.
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 Guisen Li, Doctor (+86-28-87393340, guisenli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in proteinuria levels (time frame: about 12 months). The study lists 2 primary outcomes in all. 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 Jan 2026; AzTrials last refreshed its copy on 27 Oct 2026.