A Randomized, Controlled Clinical Study of Rituximab in Treatment of Primary IgA Nephropathy

Sponsor
XIEJINGYUAN
Study ID
NCT05824390
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab group — DRUG
    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 Details

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.

Key Dates

Start date
Jun 20, 2020
Status verified
Apr 2023
Primary completion
Oct 1, 2023
Completion
Oct 1, 2023

Study Design

Enrollment
116 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A ( ACEi and / or ARB + rituximab group )
    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.
  • No Intervention: Group B ( ACEi and / or ARB )
    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.

Primary Outcome Measure

Changes in proteinuria levels over 1 year compared with baseline [ Time Frame: 1 year ]

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