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NCT04221477 · BASELINE

Baseline characteristics

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis · Source last updated 2026-07-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      135
    2. group Id
      BG001
      value
      136
    3. group Id
      BG002
      value
      271
    units
    Participants
groups
  1. description
    Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80.
    id
    BG000
    title
    Obinutuzumab
  2. description
    Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.5
          value
          33.0
        2. group Id
          BG001
          spread
          10.0
          value
          32.7
        3. group Id
          BG002
          spread
          10.2
          value
          32.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          229
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          42
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          156
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          102
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          51
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          16
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          40
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          129
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          20
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, demographic and baseline characteristics were to be provided for obinutuzumab (combined treatment groups) and placebo groups.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      135
    2. group Id
      BG001
      value
      136
    3. group Id
      BG002
      value
      271
    units
    Participants
groups
  1. description
    Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80.
    id
    BG000
    title
    Obinutuzumab
  2. description
    Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.5
          value
          33.0
        2. group Id
          BG001
          spread
          10.0
          value
          32.7
        3. group Id
          BG002
          spread
          10.2
          value
          32.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          229
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          42
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          156
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          102
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          51
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          16
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          40
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          129
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          20
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, demographic and baseline characteristics were to be provided for obinutuzumab (combined treatment groups) and placebo groups.

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