Rituximab and RASi in Patients with IgAN

Sponsor
Nan Chen,MD
Study ID
NCT04525729
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    To evaluate the efficacy and safety of HLX01 combined with RASi in patients with IgAN.
  • RAS 2410 — DRUG
    To evaluate the efficacy and safety of RASi in patients with IgAN.

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
Jul 1, 2020
Status verified
Mar 2025
Primary completion
Mar 30, 2024
Completion
Mar 30, 2024

Study Design

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

Arms

  • Experimental: Rituximab+RASi(ACEI and/or ARB)
    The 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.
  • Other: RASi(ACEI and/or ARB）
    The maximum tolerable dose of RASi will be using everyday depending on the individual factors of the subject.

Primary Outcome Measure

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

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