Trial · NCT03681184
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 6 | Baseline to Month 6 | FAS: All randomized participants who received any amount of study drug. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in 24-hour Urinary Oxalate Corrected for BSA From Baseline to Month 6 | Baseline to Month 6 | FAS: All randomized participants who received any amount of study drug. | mmol/24hr/1.73m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in 24-hour Urinary Oxalate:Creatinine Ratio From Baseline to Month 6 | Baseline to Month 6 | FAS: All randomized participants who received any amount of study drug. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With 24-hour Urinary Oxalate Level Corrected for BSA at or Below 1.5 x ULN at Month 6 | Month 6 | Participants from the FAS (all randomized participants who received any amount of study drug) for whom data are available. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 24-hour Urinary Oxalate Level Corrected for BSA at or Below ULN at Month 6 | Month 6 | Participants from the FAS (all randomized participants who received any amount of study drug) for whom data are available. | percentage of participants | NUMBER |
| SECONDARY | Percentage Change in Plasma Oxalate From Baseline to Month 6 | Baseline to Month 6 | Plasma Oxalate Analysis Set: all participants who received any amount of study drug and had baseline plasma oxalate level ≥1.5×lower limit of quantitation (LLOQ). LLOQ is 5.55 μmol/L. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Plasma Oxalate From Baseline to Month 6 | Baseline to Month 6 | Plasma Oxalate Analysis Set: all participants who received any amount of study drug and had baseline plasma oxalate level ≥1.5×LLOQ. LLOQ is 5.55 μmol/L. | μmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Week 2 and Months 1, 2, 3, 4, 5 and 6 | Baseline, Week 2, Months 1, 2, 3, 4, 5 and 6 | Participants from the FAS (all randomized participants who received any amount of study drug) for whom data are available. | mL/min/1.73m^2 | MEAN |
| SECONDARY | Absolute Change in 24-hour Urinary Oxalate Excretion Corrected for BSA From Baseline in the Extension Period | From Baseline to Month 54 and Month 60 | All Lumasiran Treated Set: All participants who received any amount of lumasiran including participants who took lumasiran during the 6-month double-blinded period and participants who initially took placebo during the 6-month double-blinded period and then switched to lumasiran during the extension period. Overall number analyzed is number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | mmol/24hr/1.73m^2 | MEAN |
| SECONDARY | Percentage Change in 24-hour Urinary Oxalate Excretion Corrected by BSA From Baseline in the Extension Period | From Baseline to Month 54 and Month 60 | All Lumasiran Treated Set: All participants who received any amount of lumasiran including participants who took lumasiran during the 6-month double-blinded period and participants who initially took placebo during the 6-month double-blinded period and then switched to lumasiran during the extension period. Overall number analyzed is number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | percent change | MEAN |
| SECONDARY | Percentage of Time That 24-hour Urinary Oxalate is at or Below 1.5 × ULN During Lumasiran Treatment | Up to Month 60 | All Lumasiran Treated Set: All participants who received any amount of lumasiran including participants who took lumasiran during the 6-month double-blinded period and participants who initially took placebo during the 6-month double-blinded period and then switched to lumasiran during the extension period. | percentage of time | MEDIAN |
| SECONDARY | Absolute Change in 24-hour Urinary Oxalate:Creatinine Ratio From Baseline in the Extension Period | From Baseline to Month 54 and Month 60 | All Lumasiran Treated Set: All participants who received any amount of lumasiran including participants who took lumasiran during the 6-month double-blinded period and participants who initially took placebo during the 6-month double-blinded period and then switched to lumasiran during the extension period. Overall number analyzed is number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | mmol/mmol | MEAN |
| SECONDARY | Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline in the Extension Period | From Baseline to Month 54 and Month 60 | All Lumasiran Treated Set: All participants who received any amount of lumasiran including participants who took lumasiran during the 6-month double-blinded period and participants who initially took placebo during the 6-month double-blinded period and then switched to lumasiran during the extension period. Overall number analyzed is number of participants with data available for analysis. Number analysed is the number of participants with data available for analysis at the specified timepoint. | mL/min/1.73m^2 | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | DB Period (Placebo): From first dose of study drug (Day 1) up to Month 6; Placebo/Lumasiran: From first dose of lumasiran (Month 6) up to end of study (Month 60); Lumasiran/Lumasiran: From first dose of lumasiran (Day 1) up to end of study (Month 60). | Per the SAP, long-term safety of lumasiran (in the extension period \[EP\]) was to be summarized by treatment sequence (placebo/lumasiran \& lumasiran/lumasiran) using the All Lumasiran Treated Set. In this set, data is presented during lumasiran treatment only. The lumasiran/lumasiran arm received lumasiran in both DB \& EP period hence, safety data is reported together for DB+EP period for this arm. Placebo/Lumasiran: first day of lumasiran dosing (Month 6) was considered baseline (Day 1) of EP. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Rate of Renal Stone Events | 12-Month Period prior to Informed Consent, 6-Month DB Period | FAS: All randomized participants who received any amount of study drug. | events per person-year | NUMBER |
| OTHER_PRE_SPECIFIED | Change From Baseline in Nephrocalcinosis as Assessed by Renal Ultrasound | Baseline, Month 6 | Participants from the FAS (all randomized participants who received any amount of study drug) with both Baseline and Month 6 renal ultrasounds. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
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