Trial · NCT04564339
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Absolute Protein (Based on 24-hour Urine Collections) | Baseline, Week 26 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | percentage change | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | LN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Urine Protein to Creatinine Ratio (UPCR) (Based on 24-hour Urine Collections) | Baseline, Week 26 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | percentage change | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by Absolute Protein (Based on 24-hour Urine Collections) | Baseline, Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | percentage change | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | LN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by UPCR (Based on 24-hour Urine Collections) | Baseline, Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | percentage change | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | IgAN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections | Baseline to Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | LN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections | Baseline to Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. | percentage of participants | NUMBER |
| SECONDARY | IgAN Cohort: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | mL/min/1.73 m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | LN Cohort: Change From Baseline in eGFR at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | mL/min/1.73 m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | IgAN Cohort: Change From Baseline in Serum Complement Component 3 (C3) and Complement Component 4 (C4) Concentrations at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | grams/liter | MEAN |
| SECONDARY | LN Cohort: Change From Baseline in Serum C3 and C4 Concentrations at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | grams/liter | LEAST_SQUARES_MEAN |
| SECONDARY | LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response (CRR) | Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. | percentage of participants | NUMBER |
| SECONDARY | LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response (PRR) | Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. | percentage of participants | NUMBER |
| SECONDARY | LN Cohort: Time to Urine Protein to Creatinine Ratio (UPCR) < 0.5 g/g, as Measured by Spot Urine Samples | Baseline through Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | days | MEDIAN |
| SECONDARY | LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 Milligrams (mg)/Day | Week 14, Week 26, and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | LN Cohort: Percentage of Participants With Renal Flare | Baseline through Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. | percentage of participants | NUMBER |
| SECONDARY | LN Cohort: Percentage of Participants With Extrarenal Systemic Lupus Erythematosus (SLE) Flare | Baseline through Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. | percentage of participants | NUMBER |
| SECONDARY | LN Cohort: Percentage of Participants With Treatment Failure | Baseline through Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. | percentage of participants | NUMBER |
| SECONDARY | LN Cohort: Percentage of Participants With Suboptimal Response | Baseline through Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. | percentage of participants | NUMBER |
| SECONDARY | LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50 | Baseline, Week 26, Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | grams/liter | MEAN |
| SECONDARY | IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission | Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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