TriangleNCT04221477 · OUTCOME
Percentage of Participants Who Experience Death or Renal-related Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From Day 1 to Week 76
What was measured
Percentage of participants with death or renal-related events were defined as participants with one or more of the following events: Death; Treatment failure; Worsening proteinuria, defined as a confirmed ≥50% increase in UPCR to a value ≥3 g/g; Worsening eGFR, defined as a confirmed ≥30% decrease in eGFR to a value \<60. Early study withdrawal due to lack of efficacy was an intercurrent event. Participants experiencing the intercurrent event were considered as participants with events under composite strategy. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentages have been rounded off.
Analysis population: Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.
Groups in this outcome
Obinutuzumab
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.
Placebo
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.
| Group | Source count |
|---|---|
| Obinutuzumab | 135 |
| Placebo | 136 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Obinutuzumab | 18.9 | Not reported | 12.11 | 25.61 | Not reported |
| Placebo | 35.6 | Not reported | 27.50 | 43.78 | Not reported |
Source statistical analyses
- ci Lower Limit
- -27.42
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -6.23
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0026
- p Value Comment
- Ranked 5 of 7 in the fixed sequence for type I error control. P-value is nominal as the hierarchical testing stops at the first non-significant endpoint.
- param Type
- Adjusted Difference
- param Value
- -16.83
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -27.42
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -6.23
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0026
- p Value Comment
- Ranked 5 of 7 in the fixed sequence for type I error control. P-value is nominal as the hierarchical testing stops at the first non-significant endpoint.
- param Type
- Adjusted Difference
- param Value
- -16.83
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.11
- upper Limit
- 25.61
- value
- 18.9
- group Id
- OG001
- lower Limit
- 27.50
- upper Limit
- 43.78
- value
- 35.6
- denoms
- counts
- group Id
- OG000
- value
- 135
- group Id
- OG001
- value
- 136
- units
- Participants
- description
- Percentage of participants with death or renal-related events were defined as participants with one or more of the following events: Death; Treatment failure; Worsening proteinuria, defined as a confirmed ≥50% increase in UPCR to a value ≥3 g/g; Worsening eGFR, defined as a confirmed ≥30% decrease in eGFR to a value \<60. Early study withdrawal due to lack of efficacy was an intercurrent event. Participants experiencing the intercurrent event were considered as participants with events under composite strategy. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentages have been rounded off.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- title
- Obinutuzumab
- 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
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.
- reporting Status
- POSTED
- time Frame
- From Day 1 to Week 76
- title
- Percentage of Participants Who Experience Death or Renal-related Events
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice