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IgA NephropathyPhase 4RITANCT04525729

Rituximab and RASi in Patients with IgAN

A Phase 4 study testing Rituximab and RAS 2410 in people with IgA Nephropathy, run by Nan Chen,MD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 and RAS 2410
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteChina
Study dates
1 Jul 2020to 30 Mar 2024
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

  • 1. 18 to 75 of age, male or female;
  • 2. primary IgA nephropathy confirmed by renal biopsy
  • 3. eGFR>30ml/min/1.73m2(calculated according to the CKD-EPI formula);
  • 4. After using maximum tolerated doses of ACEI and/or ARB for 3 months, the following two points should be met:
  • 24h proteinuria ≥1g;
  • Bp<130/80 mmHg；
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  • 5. Serum albumin > 25g/L;
  • 6. 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 :
  • ) 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

  • 1. Evidence of the use of glucocorticoids for immunosuppressive therapy, 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 %.
  • 2. Clinical confirmation of cirrhosis, chronic active liver disease, or hepatitis B, C, or HIV which can detect viral replication;
  • 3. Clinically confirmed IgA nephropathy secondary to systemic diseases such as systemic lupus erythematosus, allergic purpura.
  • 4. Patients with non-simple IgA nephropathy, such as diabetic nephropathy or obesity-related nephropathy.
  • 5. A history of active systemic infection or severe infection occurred one month before enrollment.
  • 6. Those who are pregnant or lactating or unwilling to take contraceptive measures.
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  • 7. Current or recent ( within 30 days ) exposure to any research drug.
  • 8. Patients with allergic reactions to rituximab and / or known allergic reactions.
  • 9. Laboratory tests meeting the following criteria should be excluded:
  • Hemoglobin <80g/L; (2) Platelet <80×10^9/L; (3) Neutrophils < 1.0×10^9/L; (4) Aspartic acid aminotransferase (AST) or alanine aminotransferase (ALT) >2.5× normal upper limit, except for the correlation with the primary disease;
  • 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. Weight less than 50kg should be excluded;
  • 17. Other researchers judge the patients unsuitable for inclusion in the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Multicentre, Randomized, Controlled Study of Rituximab in Treatment of Primary IgA Nephropathy

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, RAS 2410
Keywords
IgAN, Rituximab, RASi, Gd-IgA1, proteinuria
Medical subject headings
Glomerulonephritis, IGA, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called HLX01

    To evaluate the efficacy and safety of HLX01 combined with RASi in patients with IgAN.

  • RAS 2410Drug

    Also called No specific restrictions

    To evaluate the efficacy and safety of RASi in patients with IgAN.

Study groups in NCT04525729
Study groupRoleWhat they receive
Rituximab+RASi(ACEI and/or ARB)ExperimentalThe maximum tolerable dose of RASi will be using everyday depending on the individual factors of the subject, combined with rituximab 1g(D1, D31 respectively, intravenous infusion). Add 1 g rituximab at 6 months.
Receives: Drug: Rituximab; Drug: RAS 2410
RASi(ACEI and/or ARB）OtherThe maximum tolerable dose of RASi will be using everyday depending on the individual factors of the subject.
Receives: Drug: RAS 2410

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in proteinuria levels over 1 year compared with baseline

    Primary outcome included changes in proteinuria levels over 1 year compared with baseline

    Measured: 1 year

Secondary outcomes (9)

  1. 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

  2. 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

  3. Changes in proteinuria levels over 6 months compared with baseline

    Secondary Outcome included changes in proteinuria levels over 6 months compared with baseline

    Measured: 6 months

  4. Changes in eGFR levels over 1 year compared with baseline

    To evaluate the efficacy of treatment in renal function

    Measured: 1 year

  5. Changes in Gd-IgA1 levels

    To observe the changes in GD-IGA1 level

    Measured: 1 year

  6. Incidence of adverse events

    Record the safety of Interventional drugs

    Measured: 1 year

  7. Incidence of ESRD

    Evaluate the efficacy of treatment

    Measured: 1 year

  8. The proportion of 50% reduction in eGFR levels or doubling serum creatinine compared with baseline

    To evaluate the renal function

    Measured: 1 year

  9. Incidence of infection

    To evaluate the safety of Rituximab

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2020
  2. Study start1 Jul 2020
  3. Primary completion30 Mar 2024
  4. Study completion30 Mar 2024

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04525729
Sponsor's protocol ID
RITA
Acronym
RITA
Status last verified
Mar 2025
First submitted
17 Aug 2020
Last updated
14 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

    PubMed 38299639

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rituximab and RAS 2410 in people with IgA Nephropathy, run by Nan Chen,MD 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 13 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: finished, as of the sponsor's last update on 14 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

On the ClinicalTrials.gov record for NCT04525729, which also lists 1 linked publication.

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 14 Mar 2025.

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