Trial · NCT04152200
Outcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohort A: Percent Change in Plasma Oxalate From Baseline to Month 6 | Baseline to Month 6 | Full Analysis Set (FAS): All patients who received any amount of lumasiran and had at least 1 evaluable plasma oxalate value (pre-dialysis in Cohort B) at baseline and at least 1 evaluable plasma oxalate value from assessment(s) at Month 3 through Month 6. | percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Cohort B: Percent Change in Pre-dialysis Plasma Oxalate From Baseline to Month 6 | Baseline to Month 6 | FAS: All patients who received any amount of lumasiran and had at least 1 evaluable plasma oxalate value (pre-dialysis in Cohort B) at baseline and at least 1 evaluable plasma oxalate value from assessment(s) at Month 3 through Month 6. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Cohort B: Percent Change in Plasma Oxalate Area Under the Curve From 0-24 Hours [AUC(0-24)] Between Dialysis Sessions From Baseline to Month 6 | Baseline to Month 6 | FAS: All patients who received any amount of lumasiran and had at least 1 evaluable plasma oxalate value (pre-dialysis in Cohort B) at baseline and at least 1 evaluable plasma oxalate value from assessment(s) at Month 3 through Month 6. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Plasma Oxalate From Baseline to Month 6 | Baseline to Month 6 | FAS: All patients who received any amount of lumasiran and had at least 1 evaluable plasma oxalate value (pre-dialysis in Cohort B) at baseline and at least 1 evaluable plasma oxalate value from assessment(s) at Month 3 through Month 6. | μmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Cohort A: Absolute Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 6 | Baseline to Month 6 | FAS: All patients who received any amount of lumasiran (with data available for analysis) and had at least 1 evaluable plasma oxalate value (pre-dialysis in Cohort B) at baseline and at least 1 evaluable plasma oxalate value from assessment(s) at Month 3 through Month 6. No analyses were performed for patients in Cohort B that were anuric (ie, patients able to continue to produce urine ≥100 mL per day). | mmol/24hr/1.73m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Cohort A: 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 patients who received any amount of lumasiran (with data available for analysis) and had at least 1 evaluable plasma oxalate value (pre-dialysis in Cohort B) at baseline and at least 1 evaluable plasma oxalate value from assessment(s) at Month 3 through Month 6. No analyses were performed for patients in Cohort B that were anuric (ie, patients able to continue to produce urine ≥100 mL per day). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Cohort A: Absolute Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 6 | Baseline to Month 6 | FAS: All patients who received any amount of lumasiran and had at least 1 evaluable plasma oxalate value (pre-dialysis in Cohort B) at baseline and at least 1 evaluable plasma oxalate value from assessment(s) at Month 3 through Month 6. | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Cohort A: Percent Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 6 | Baseline to Month 6 | FAS: All patients who received any amount of lumasiran and had at least 1 evaluable plasma oxalate value (pre-dialysis in Cohort B) at baseline and at least 1 evaluable plasma oxalate value from assessment(s) at Month 3 through Month 6. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Quality of Life As Assessed by Pediatric Quality of Life Inventory (PedsQL) Total Score From Baseline to Month 6 in Patients >=2 to 18 Years of Age at Time of Informed Consent | Baseline to Month 6 | Participants from the FAS who were ≥2 to \<18 years of age at the time of consent with data available for analysis. | score on a scale | MEAN |
| SECONDARY | Change in Quality of Life As Assessed by Kidney Disease and Quality of Life (KDQOL) Scores From Baseline to Month 6 in Patients ≥18 Years of Age at Time of Informed Consent | Baseline to Month 6 | Participants from the FAS who were ≥18 years of age at the time of consent. | score on a scale | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Lumasiran | Day 1; Month 6 | Pharmacokinetic (PK) Analysis Set: All patients who received any amount of lumasiran, have at least 1 postdose blood sample for PK parameters, and have evaluable PK data. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Maximum Plasma Concentration (Tmax) of Lumasiran | Day 1; Month 6 | PK Analysis Set: All patients who received any amount of lumasiran, have at least 1 postdose blood sample for PK parameters, and have evaluable PK data. | hours | MEDIAN |
| SECONDARY | Elimination Half-life (t½β) of Lumasiran | Day 1; Month 6 | PK Analysis Set: All patients who received any amount of lumasiran, have at least 1 postdose blood sample for PK parameters, and have evaluable PK data at the given timepoint. | hours | MEDIAN |
| SECONDARY | Area Under the Concentration-time Curve From 0 to 24 Hours [AUC(0-24)] for Lumasiran | Day 1; Month 6 | PK Analysis Set: All patients who received any amount of lumasiran, have at least 1 postdose blood sample for PK parameters, and have evaluable PK data at the given timepoint. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Apparent Clearance (CL/F) of Lumasiran | Day 1; Month 6 | PK Analysis Set: All patients who received any amount of lumasiran, have at least 1 postdose blood sample for PK parameters, and have evaluable PK data at the given timepoint. | Liters/hour (L/h) | GEOMETRIC_MEAN |
| SECONDARY | Apparent Volume of Distribution (V/F) of Lumasiran | Day 1; Month 6 | PK Analysis Set: All patients who received any amount of lumasiran, have at least 1 postdose blood sample for PK parameters, and have evaluable PK data at the given timepoint. | Liters (L) | GEOMETRIC_MEAN |
| SECONDARY | Percent Change in Plasma Oxalate Area Under the Curve From 0-24 Hours [AUC(0-24)] Between Dialysis Sessions From Baseline to Month 60 | Baseline to Month 60 | |||
| SECONDARY | Absolute Change in Plasma Oxalate From Baseline to Month 60 | Baseline to Month 60 | |||
| SECONDARY | Absolute Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 60 | Baseline to Month 60 | |||
| SECONDARY | Percent Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 60 | Baseline to Month 60 |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04152200/outcomes