IgA Nephropathy (IgAN)NCT07822100
To Assess the Efficacy and Safety of Utilizing Galactose-deficient IgA1 Biomarker Changes to Guide Pathogenic IgA-targeted Therapeutic Strategies
A study testing Gd-IgA1 monitoring in people with IgA Nephropathy (IgAN) and Henoch Schönlein Purpura Nephritis, run by Hong Zhang at 1 site in China.
Trial summary
The goal of this open-label, randomized study is to evaluate the efficacy and safety of the personalized treatment model in which Gd-IgA1 is dynamically monitored to guide medication adjustment in progressive IgAN patients treated with Nefecon or telitacicept. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IgA Nephropathy (IgAN), Henoch Schönlein Purpura Nephritis
- What is being tested?
- Gd-IgA1 monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2026to Feb 2028
- Phase
- Interventional
- 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
Who may be able to join
- Male or female, between 18 and 75 years age;
- Biopsy confirmed diagnosis of primary IgA nephropathy or IgA Vasculitis-Associated Nephritis;
- Persistent proteinuria, defined as: two separate measurements (with an interval of ≥ 4 weeks) of 24-hour urinary protein excretion (24hUTP) ≥ 0.5 g/day, or urine protein-to-creatinine ratio (UPCR) ≥ 0.44 g/g;
- Estimated glomerular filtration rate (eGFR) (CKD-EPI) ≥ 30 ml/min per 1.73m^2;
- Have received the angiotensin converting enzyme Inhibitors(ACEI) / angiotensin receptor blocker(ARB) standard treatment for 4 weeks prior to randomization;
- Intending to receive or having received Nefecon or telitacicept treatment for ≤ 2 weeks at the time of screening.
Who cannot join
- Secondary IgA nephropathy (excluding IgA vasculitis) caused by ankylosing spondylitis, systemic lupus erythematosus, viral hepatitis, liver cirrhosis, etc.;
- With a known history or clinical evidence of concurrent renal diseases other than IgA nephropathy;
- Treating with systemic corticosteroids or immunosuppressants including cyclophosphamide, azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, rituximab, etc. within 3 months prior to randomizing;
- Have initiated or had a dose adjustment of leflunomide, tripterygium wilfordii or hydroxychloroquine within 3 months prior to randomizing;
- Active tuberculosis or latent carrier without treatment;
- Herpes zoster infected patients or patients with positive HIV antibody, positive HCV antibody or HBV infection (According to the HBV screening test, a) the HBsAg-positive; b) HBsAg-negative and HBcAb-positive, the HBV-DNA should be tested to determine the situation: the HBV-DNA positive subjects should be excluded, while the HBV-DNA negative subjects can participated in.)
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- Suffering from following gastrointestinal diseases: gastric ulcer bleeding within the past 6 months, active inflammatory bowel disease, a history of major gastrointestinal surgery (e.g., gastrectomy, gastroenterostomy, or bowel resection), or pancreatic injury/pancreatitis within the past 6 months;
- A confirmed history of osteoporosis or osteonecrosis of the femoral head;
- Type 1 or type 2 diabetes with poor glycemic control (HbA1c > 8%);
- Body mass index (BMI) < 18.5 kg/m².;
- Systolic blood pressure (SBP) > 180 mmHg or diastolic blood pressure (DBP) > 110 mmHg;
- Decreased lymphocyte count (absolute value < 1.1 × 10⁹/L) or decreased immunoglobulin G (IgG < 6 g/L).
- Hepatic dysfunction, meeting any of the following: a) Child-Pugh Class C liver dysfunction; b) ALT or AST > 2 × upper limit of normal (ULN), or total bilirubin > 2 × ULN at screening; c) history of hepatic encephalopathy, esophageal varices, or portosystemic shunt surgery;
- Evidence of urinary tract obstruction or dysuria.
- A history of solid organ transplantation, hematopoietic stem cell/cell/bone marrow transplantation, or kidney transplantation.
- Pregnancy, lactation, female participants with childbearing plans during the trial or within 6 months of its completion, and male participants planning to conceive or donate sperm during the trial or within 3 months of its completion;
- With a history of malignant tumors within the past 5 years (excluding cutaneous squamous cell carcinoma or basal cell carcinoma);
- Allergy to human-derived biologics;
- Nephrotoxic drugs is unavoidable during the study period;
- Not suitable for the study judged by investigator.
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
Peking University First Hospital
Beijing, Beijing Municipality, 100010
Yunfei Bao, 086-18500228190, baoy_fei@163.com
About this study
Official title: Development and Validation of a Gd-IgA1 Guided Precision Therapy System for Targeted Therapeutic Strategies of IgA Nephropathy： An Open-label, Random Controlled Trial
The goal of this open-label, randomized study is to evaluate the efficacy and safety of the personalized treatment model in which Gd-IgA1 is dynamically monitored to guide medication adjustment in progressive IgAN patients treated with Nefecon or telitacicept.
Researchers will compare two groups of participants: those who have Gd-IgA1 checked regularly during treatment, and those who do not. This is to find out if regular Gd-IgA1 checks can help doctors adjust medication better and get better treatment results.
Read the detailed description
IgA nephropathy (IgAN) is the most common primary glomerulonephritis worldwide and a leading cause of end-stage renal disease (ESRD) in young adults. Even with standard supportive care, many patients still experience worsening renal function and eventually develop ESRD.
The widely accepted multi-hit pathogenesis of IgAN recognizes the production of galactose-deficient IgA1 (Gd-IgA1) as the key step. Pathogenic Gd-IgA1 forms immune complexes that deposit in the kidney, triggering inflammation and renal damage, which serves as a target for new regimens.
Two novel targeted therapies have shown positive clinical effects for IgAN:
- Budesonide Enteric Capsules (Nefecon): A gut-targeted oral preparation that releases drugs in the ileocecal region, reducing Gd-IgA1 production and renal immune deposition to protect renal function.
- Telitacicept: A dual Blys/APRIL inhibitor that blocks the proliferation of B cells to reduce pathogenic Gd-IgA1 production.
However, the clinical effects of these novel therapies usually take time to appear (e.g., a significant drop in urinary protein with Nefecon is often seen 3 to 6 months after treatment). Early, sensitive indicators reflecting therapeutic effects are needed to enable timely adjustment of treatment plans.
Biomarkers (e.g., Gd-IgA1) decline earlier than urinary protein, which is highly significant for monitoring early treatment efficacy and optimizing personalized treatment decisions.
- Being tested
- Gd-IgA1 monitoring
- Keywords
- IgA Nephropathy, IgA Vasculitis Nephritis, Gd-IgA1
- 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 monitoringDiagnostic test
Participants in the experimental group will undergo a total of five Gd-IgA1 tests at baseline and during the follow-up period, and their clinicians will use these results to guide medication adjustment.
| Study group | Role | What they receive |
|---|---|---|
| Participants who have Gd-IgA1 checked regularly during treatment | Experimental | Based on the combined results of reductions in urinary protein, Gd-IgA1 levels and other parameters, clinicians can thus evaluate early treatment efficacy and make timely medication adjustments - either continuing the original treatment, increasing the dose, or switching to another medication. Receives: Diagnostic Test: Gd-IgA1 monitoring |
| Participants who do not have Gd-IgA1 checked during treatment | No intervention | Clinicians will make medication adjustment base on urinary protein and other laboratory test parameters if necessary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in 24-hour proteinuria from baseline at the end of follow-up
Measured: From enrollment to the end of follow-up at 12 months
Secondary outcomes (4)
Mean change in 24-hour proteinuria from baseline at the midpoint of follow-up
Measured: From enrollment to the middle of follow-up period at 6 months
Change in estimated glomerular filtration rate (eGFR)
eGFR is calculated using the CKD-EPI method.
Measured: From enrollment to the end of follow-up at 12 months
Complete remission of proteinuria
24-hour urine total protein ≤ 0.3 g with a concurrent eGFR decline ≤ 30%
Measured: From enrollment to the midpoint of follow-up (6 months) and over the entire 12-month follow-up period
Immunosuppressant exposure measures
Cumulative dosage of non-corticosteroid immunosuppressants, cumulative dosage of systemic corticosteroids converted to prednisone-equivalent dosage, and number of corticosteroid bolus therapy courses during follow-up. Consecutive daily bolus doses count as one course; topical corticosteroids are excluded.
Measured: From enrollment to the end of follow-up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start24 Aug 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hong Zhang, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822100
- Sponsor's protocol ID
- 2025R0625
- Other IDs
- 2024YFC2511000
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Gd-IgA1 Guided Precision Therapy System for Targeted Therapeutic Strategies of IgA Nephropathy： An Open-label, Random Controlled Trial
- ClinicalTrials.gov ID
- NCT07822100
- Acronym / sponsor ID
- 2025R0625
- Keywords
- IgA Nephropathy, IgA Vasculitis Nephritis, Gd-IgA1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Hong ZhangUniversity, hospital or other
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 16 Sep 2026 (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.
The goal of this open-label, randomized study is to evaluate the efficacy and safety of the personalized treatment model in which Gd-IgA1 is dynamically monitored to guide medication adjustment in progressive IgAN patients treated with Nefecon or telitacicept.
Researchers will compare two groups of participants: those who have Gd-IgA1 checked regularly during treatment, and those who do not. This is to find out if regular Gd-IgA1 checks can help doctors adjust medication better and get better treatment results.
Detailed description
IgA nephropathy (IgAN) is the most common primary glomerulonephritis worldwide and a leading cause of end-stage renal disease (ESRD) in young adults. Even with standard supportive care, many patients still experience worsening renal function and eventually develop ESRD.
The widely accepted multi-hit pathogenesis of IgAN recognizes the production of galactose-deficient IgA1 (Gd-IgA1) as the key step. Pathogenic Gd-IgA1 forms immune complexes that deposit in the kidney, triggering inflammation and renal damage, which serves as a target for new regimens.
Two novel targeted therapies have shown positive clinical effects for IgAN:
- Budesonide Enteric Capsules (Nefecon): A gut-targeted oral preparation that releases drugs in the ileocecal region, reducing Gd-IgA1 production and renal immune deposition to protect renal function.
- Telitacicept: A dual Blys/APRIL inhibitor that blocks the proliferation of B cells to reduce pathogenic Gd-IgA1 production.
However, the clinical effects of these novel therapies usually take time to appear (e.g., a significant drop in urinary protein with Nefecon is often seen 3 to 6 months after treatment). Early, sensitive indicators reflecting therapeutic effects are needed to enable timely adjustment of treatment plans.
Biomarkers (e.g., Gd-IgA1) decline earlier than urinary protein, which is highly significant for monitoring early treatment efficacy and optimizing personalized treatment decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants who have Gd-IgA1 checked regularly during treatment | Experimental | Diagnostic Test: Gd-IgA1 monitoringBased on the combined results of reductions in urinary protein, Gd-IgA1 levels and other parameters, clinicians can thus evaluate early treatment efficacy and make timely medication adjustments - either continuing the original treatment, increasing the dose, or switching to another medication. |
| Participants who do not have Gd-IgA1 checked during treatment | No intervention | –Clinicians will make medication adjustment base on urinary protein and other laboratory test parameters if necessary. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, between 18 and 75 years age;
- Biopsy confirmed diagnosis of primary IgA nephropathy or IgA Vasculitis-Associated Nephritis;
- Persistent proteinuria, defined as: two separate measurements (with an interval of ≥ 4 weeks) of 24-hour urinary protein excretion (24hUTP) ≥ 0.5 g/day, or urine protein-to-creatinine ratio (UPCR) ≥ 0.44 g/g;
- Estimated glomerular filtration rate (eGFR) (CKD-EPI) ≥ 30 ml/min per 1.73m^2;
- Have received the angiotensin converting enzyme Inhibitors(ACEI) / angiotensin receptor blocker(ARB) standard treatment for 4 weeks prior to randomization;
Key exclusion criteria (20 listed)
- Secondary IgA nephropathy (excluding IgA vasculitis) caused by ankylosing spondylitis, systemic lupus erythematosus, viral hepatitis, liver cirrhosis, etc.;
- With a known history or clinical evidence of concurrent renal diseases other than IgA nephropathy;
- Treating with systemic corticosteroids or immunosuppressants including cyclophosphamide, azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, rituximab, etc. within 3 months prior to randomizing;
- Have initiated or had a dose adjustment of leflunomide, tripterygium wilfordii or hydroxychloroquine within 3 months prior to randomizing;
- Active tuberculosis or latent carrier without treatment;
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 monitoringParticipants in the experimental group will undergo a total of five Gd-IgA1 tests at baseline and during the follow-up period, and their clinicians will use these results to guide medication adjustment. | Diagnostic test | Participants who have Gd-IgA1 checked regularly during treatment |
Primary outcome
Mean change in 24-hour proteinuria from baseline at the end of follow-up
Time frame: From enrollment to the end of follow-up at 12 months
4 secondary outcomes
Mean change in 24-hour proteinuria from baseline at the midpoint of follow-up
Time frame: From enrollment to the middle of follow-up period at 6 months
Change in estimated glomerular filtration rate (eGFR)
Time frame: From enrollment to the end of follow-up at 12 months
Complete remission of proteinuria
Time frame: From enrollment to the midpoint of follow-up (6 months) and over the entire 12-month follow-up period
Immunosuppressant exposure measures
Time frame: From enrollment to the end of follow-up at 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 16 Sep 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?
A study testing Gd-IgA1 monitoring in people with IgA Nephropathy (IgAN) and Henoch Schönlein Purpura Nephritis, run by Hong Zhang 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 6 inclusion and 20 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 16 Sep 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 Yunfei Bao (086-18500228190, baoy_fei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in 24-hour proteinuria from baseline at the end of follow-up (time frame: From enrollment to the end of follow-up at 12 months). 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 16 Sep 2026.