IgA NephropathyPhase 4NCT05824390
A Randomized, Controlled Clinical Study of Rituximab in Treatment of Primary IgA Nephropathy
A Phase 4 study testing rituximab group in people with IgA Nephropathy, run by XIEJINGYUAN at 1 site in China.
Trial summary
A study to evaluate safety and activity in treatment of IgAN patients using Rituximab in combination with RASi(ACEI and/or ARB) compared with RASi. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- rituximab group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2020to 1 Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Age 18-75 years old, no gender limit;
- Renal biopsy confirmed primary IgA nephropathy;
- Assess glomerular filtration rate ( eGFR )>30ml/min/1.73m2 (calculated according to the CKD-EPI formula);
- After 3 months of treatment with the maximum tolerated dose of ACEI and/or ARB, the following two points should be met:
- 1) 24hurinary protein ≥ 1g; 2) Blood pressure <130/80 mmHg; 5. Serum albumin> 25g/L; 6. Voluntarily sign the informed consent.
- Note : It is suggested that active IgAN patients should be selected. Active IgAN is specifically defined as conforming to any of the following :
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- ) intradermal augmentation ( E1 ),
- ) crescentic body 0 - 50 % ( C1 / C2 ),
- ) fibrinoid necrosis,
- ) more interstitial inflammatory cell infiltration. At the same time, the proportion of sclerosis was low ( spherical or segmental sclerosis ball < 50 % ), and interstitial fibrosis was low ( below T2 ).
Who cannot join
- Glucocorticoid used for immunosuppressive therapy indications, such as : nephrotic syndrome, pathology for small lesions with IgA nephropathy. or the proportion of crescents confirmed by renal biopsy within 12 months was more than 50 %.
- Clinically confirmed cirrhosis, chronic active liver disease or hepatitis B, hepatitis C or HIV can detect viral replication.
- Clinically confirmed IgA nephropathy secondary to systemic diseases such as systemic lupus erythematosus, allergic purpura.
- Patients with non-simple IgA nephropathy, such as diabetic nephropathy or obesity-related nephropathy.
- A history of active systemic infection or severe infection occurred one month before enrollment.
- Those who are pregnant or lactating or unwilling to take contraceptive measures.
Show all 10Show fewer
- Current or recent ( within 30 days ) exposure to any research drug. 8. Patients with allergic reactions to rituximab and / or known allergic reactions.
- Patients with allergic reactions to rituximab and / or known allergic reactions.
- Laboratory tests should be excluded if they meet the following standards :
- Hemoglobin <80g/L; (2) Platelets<80×109/L; (3) Neutrophils <1.0×109/L; (4) In addition to being related to the primary disease, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>2.5×upper limit of normal; 10. Continuous use of hormones or other immunosuppressive therapy in the past 6 months; 11. Accompanying or past malignant tumors, except for fully treated skin basal or squamous cell carcinoma or cervical carcinoma in situ; 12. History of psychosis may interfere with normal participation in this study; 13. Patients with major heart or lung diseases (including obstructive pulmonary disease); 14. In acute and chronic tuberculosis infection period (tuberculin test positive, chest X-ray suspected tuberculosis patients); 15. Patients with history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 16. Low weight (weight < 50kg) should be excluded; 17. Other investigators judged patients unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200001
About this study
A study to evaluate safety and activity in treatment of IgAN patients using Rituximab in combination with RASi(ACEI and/or ARB) compared with RASi.
Read the detailed description
IgA nephropathy (IgAN, IgA nephropathy), is currently the most common glomerular disease worldwide, which is characterized by High population quantity, wide distribution, strong heterogeneity.
Diagnosis of Urinary protein control level within 1 year is one of the important predictors of renal failure in IgAN patients.Previous studies have shown that patients with renal insufficiency, hypertension, or urinary protein > 1g at 24h during renal biopsy, and those with poor urinary protein control within 1 year of follow-up, have a higher risk of disease progression, and more than 30-50% of patients will develop into end-stage renal disease (ESRD) within 10 years.
The recommended treatments for IgAN in the KDIGO guidelines include: RASi, glucocorticoid, immunosuppressor, antiplatelet drugs, lipid-lowering drugs, etc. Several trials have demonstrated the benefit of RASi in retarding disease progression in IgAN patients with proteinuria, but there is currently no specific treatment for IgAN.
In recent years, it has been found that excessive production of Galactos-deficient IgA1 is one of the initiating factors of the pathogenesis of IgAN. Infection by pathogenic microorganisms induces lymphocytes in IgAN patients to produce anti-GD-IgA1 autoantibodies (second strike), which forms circulating immune complexes to deposit in the kidney and activates complement, which is an important pathogenesis of IgAN.However, recent studies have suggested that B-cell depletion therapy is effective for many aabs mediated renal diseases (e.g., membranous nephropathy, lupus nephritis, etc.). Rituximab, which combined with CD20 antigen on the B cell surface, can deplete B cells and play a therapeutic role by reducing antibody production. Therefore, the treatment of rituximab has potential therapeutic value for IgAN patients as well.
However, there were very few studies which have shown the efficacy and safety of rituximab in the treatment of IgA nephropathy, only groups reported abroad, and the results were inconsistent. At present, there have been no randomized controlled studies to verify the safety and efficacy of rituximab in the treatment of IgA nephropathy, especially in Chinese with high incidence of IgAN.
In this study, treatment of rituximab combining with RASi will be compared with RASi for IgAN patients, to explore an effective and safer regimen for IgAN, so as to bring more hope to patients.
- Conditions
- IgA Nephropathy
- Being tested
- rituximab group
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximab groupDrug
Also called ACEi and / or ARB
Rituximab is a human-mouse chimeric monoclonal antibody specifically targeting B cell surface antigen CD20. CD20 may act as a calcium channel to play a certain signal role and participate in the regulation of B cell maturation and differentiation. Once combined with CD20, RTX consumed CD20 + B fines through antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity and direct induction of apoptosis. Recent studies have shown that B cell depletion therapy has a certain effect on many autoantibodies-mediated kidney diseases ( such as membranous nephropathy, lupus nephritis, etc. ). Therefore, rituximab combined with CD20 antigen on the surface of B cells can exhaust B cells that produce antibodies and play a therapeutic role by reducing antibody production, so this therapy also has potential therapeutic value for IgAN patients.
| Study group | Role | What they receive |
|---|---|---|
| Group A ( ACEi and / or ARB + rituximab group ) | Experimental | Patients in the experimental group were treated with the maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and / or angiotensin II receptor blocker ( ARB ) combined with rituximab. The specific usage and dosage are as follows : On the basis of the use of ACEI and / or ARB, rituximab was used on D1 and D31 days, 1 g each time, intravenous drip, twice in total. Add 1 g rituximab at 6 months. All patients who received rituximab were given oral acetaminophen ( 1g ), diphenhydramine hydrochloride ( 50mg ) and intravenous methylprednisolone ( 40mg ) 30-60min before the beginning of infusion. ACEI and / or ARB were given daily maximum tolerable dose according to individual factors of subjects. Receives: Drug: rituximab group |
| Group B ( ACEi and / or ARB ) | No intervention | According to the individual factors of the subjects, the maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and / or angiotensin II receptor blocker ( ARB ) were used daily. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in proteinuria levels over 1 year compared with baseline
changes in proteinuria levels over 1 year compared with baseline
Measured: 1 year
Secondary outcomes (9)
The proportion of 50% reduction in mean urinary protein compared with baseline over 1 year
Statistical data of proportion of 50% reduction in mean urinary protein compared with baseline over 1 year
Measured: 1 year
The proportion of 50% reduction in mean urinary protein compared with baseline over 6 months
Statistical data of proportion of 50% reduction in mean urinary protein compared with baseline over 6 months
Measured: 6 months
Changes in proteinuria levels over 6 months compared with baseline
Changes in proteinuria levels over 6 months compared with baseline
Measured: 6 months
Changes in eGFR levels over 1 year compared with baseline
changes in eGFR levels over 1 year compared with baseline
Measured: 1 year
Changes of Gd-IgA1 levels
Changes of Gd-IgA1 levels
Measured: 1 year
Incidence of adverse events
Incidence of adverse events
Measured: 1 year
Incidence of ESRD
Incidence of ESRD
Measured: 1 year
Proportion of eGFR decreased by 50 % or serum creatine doubled compared with baseline
Proportion of eGFR decreased by 50 % or serum creatinine doubled compared with baseline
Measured: 1 year
Incidence rate of infection
Incidence rate of infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start20 Jun 2020
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- XIEJINGYUAN
- Sponsor type
- University, hospital or other
- Collaborators
- Dongfang Hospital Affiliated to Tongji University, Shanghai Pudong New Area People's Hospital, Ruijin Hospital, Ningbo Municipal Yinzhou District No.2 Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Xiamen Humanity Hospital, Sir Run Run Shaw Hospital
- Responsible party
- Sponsor-investigator, XIEJINGYUAN, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824390
- Sponsor's protocol ID
- RuijinHRIGA
- Status last verified
- Apr 2023
- First submitted
- 9 Apr 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Study of Rituximab in Treatment of Primary IgA Nephropathy
- ClinicalTrials.gov ID
- NCT05824390
- Acronym / sponsor ID
- RuijinHRIGA
- Conditions
- IgA Nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (actual)
- Lead sponsor
- XIEJINGYUANUniversity, hospital or other
- Collaborators
- Dongfang Hospital Affiliated to Tongji University, Shanghai Pudong New Area People's Hospital, Ruijin Hospital, Ningbo Municipal Yinzhou District No.2 Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Xiamen Humanity Hospital, Sir Run Run Shaw Hospital
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 21 Apr 2023 (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.
A study to evaluate safety and activity in treatment of IgAN patients using Rituximab in combination with RASi(ACEI and/or ARB) compared with RASi.
Detailed description
IgA nephropathy (IgAN, IgA nephropathy), is currently the most common glomerular disease worldwide, which is characterized by High population quantity, wide distribution, strong heterogeneity.
Diagnosis of Urinary protein control level within 1 year is one of the important predictors of renal failure in IgAN patients.Previous studies have shown that patients with renal insufficiency, hypertension, or urinary protein > 1g at 24h during renal biopsy, and those with poor urinary protein control within 1 year of follow-up, have a higher risk of disease progression, and more than 30-50% of patients will develop into end-stage renal disease (ESRD) within 10 years.
The recommended treatments for IgAN in the KDIGO guidelines include: RASi, glucocorticoid, immunosuppressor, antiplatelet drugs, lipid-lowering drugs, etc. Several trials have demonstrated the benefit of RASi in retarding disease progression in IgAN patients with proteinuria, but there is currently no specific treatment for IgAN.
In recent years, it has been found that excessive production of Galactos-deficient IgA1 is one of the initiating factors of the pathogenesis of IgAN. Infection by pathogenic microorganisms induces lymphocytes in IgAN patients to produce anti-GD-IgA1 autoantibodies (second strike), which forms circulating immune complexes to deposit in the kidney and activates complement, which is an important pathogenesis of IgAN.However, recent studies have suggested that B-cell depletion therapy is effective for many aabs mediated renal diseases (e.g., membranous nephropathy, lupus nephritis, etc.). Rituximab, which combined with CD20 antigen on the B cell surface, can deplete B cells and play a therapeutic role by reducing antibody production. Therefore, the treatment of rituximab has potential therapeutic value for IgAN patients as well.
However, there were very few studies which have shown the efficacy and safety of rituximab in the treatment of IgA nephropathy, only groups reported abroad, and the results were inconsistent. At present, there have been no randomized controlled studies to verify the safety and efficacy of rituximab in the treatment of IgA nephropathy, especially in Chinese with high incidence of IgAN.
In this study, treatment of rituximab combining with RASi will be compared with RASi for IgAN patients, to explore an effective and safer regimen for IgAN, so as to bring more hope to patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A ( ACEi and / or ARB + rituximab group ) | Experimental | Drug: rituximab groupPatients in the experimental group were treated with the maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and / or angiotensin II receptor blocker ( ARB ) combined with rituximab. The specific usage and dosage are as follows : On the basis of the use of ACEI and / or ARB, rituximab was used on D1 and D31 days, 1 g each time, intravenous drip, twice in total. Add 1 g rituximab at 6 months. All patients who received rituximab were given oral acetaminophen ( 1g ), diphenhydramine hydrochloride ( 50mg ) and intravenous methylprednisolone ( 40mg ) 30-60min before the beginning of infusion. ACEI and / or ARB were given daily maximum tolerable dose according to individual factors of subjects. |
| Group B ( ACEi and / or ARB ) | No intervention | –According to the individual factors of the subjects, the maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and / or angiotensin II receptor blocker ( ARB ) were used daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-75 years old, no gender limit;
- Renal biopsy confirmed primary IgA nephropathy;
- Assess glomerular filtration rate ( eGFR )>30ml/min/1.73m2 (calculated according to the CKD-EPI formula);
- After 3 months of treatment with the maximum tolerated dose of ACEI and/or ARB, the following two points should be met:
- 1) 24hurinary protein ≥ 1g; 2) Blood pressure <130/80 mmHg; 5. Serum albumin> 25g/L; 6. Voluntarily sign the informed consent.
Key exclusion criteria (10 listed)
- Glucocorticoid used for immunosuppressive therapy indications, such as : nephrotic syndrome, pathology for small lesions with IgA nephropathy. or the proportion of crescents confirmed by renal biopsy within 12 months was more than 50 %.
- Clinically confirmed cirrhosis, chronic active liver disease or hepatitis B, hepatitis C or HIV can detect viral replication.
- Clinically confirmed IgA nephropathy secondary to systemic diseases such as systemic lupus erythematosus, allergic purpura.
- Patients with non-simple IgA nephropathy, such as diabetic nephropathy or obesity-related nephropathy.
- A history of active systemic infection or severe infection occurred one month before enrollment.
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 |
|---|---|---|
| rituximab groupAlso: ACEi and / or ARBRituximab is a human-mouse chimeric monoclonal antibody specifically targeting B cell surface antigen CD20. CD20 may act as a calcium channel to play a certain signal role and participate in the regulation of B cell maturation and differentiation. Once combined with CD20, RTX consumed CD20 + B fines through antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity and direct induction of apoptosis. Recent studies have shown that B cell depletion therapy has a certain effect on many autoantibodies-mediated kidney diseases ( such as membranous nephropathy, lupus nephritis, etc. ). Therefore, rituximab combined with CD20 antigen on the surface of B cells can exhaust B cells that produce antibodies and play a therapeutic role by reducing antibody production, so this therapy also has potential therapeutic value for IgAN patients. | Drug | Group A ( ACEi and / or ARB + rituximab group ) |
Primary outcome
Changes in proteinuria levels over 1 year compared with baseline
Time frame: 1 year
changes in proteinuria levels over 1 year compared with baseline
9 secondary outcomes
The proportion of 50% reduction in mean urinary protein compared with baseline over 1 year
Time frame: 1 year
The proportion of 50% reduction in mean urinary protein compared with baseline over 6 months
Time frame: 6 months
Changes in proteinuria levels over 6 months compared with baseline
Time frame: 6 months
Changes in eGFR levels over 1 year compared with baseline
Time frame: 1 year
Changes of Gd-IgA1 levels
Time frame: 1 year
Incidence of adverse events
Time frame: 1 year
Incidence of ESRD
Time frame: 1 year
Proportion of eGFR decreased by 50 % or serum creatine doubled compared with baseline
Time frame: 1 year
Incidence rate of infection
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 rituximab group in people with IgA Nephropathy, run by XIEJINGYUAN 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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in proteinuria levels over 1 year compared with baseline (time frame: 1 year). 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 21 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.