Trial · NCT06465472
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | % change in 24-hour urinary oxalate excretion corrected for body surface area (BSA) determined from 24-hour urine sample collections | % change in 24-hour urinary oxalate excretion between baseline value and value at month 6 | % change in 24-hour urinary oxalate excretion in mg/kg corrected for body surface area (BSA) between baseline and Month 6 and determined from 24-hour urine sample collections |
| Secondary | % change in 24-hour urinary oxalate excretion corrected for body surface area (BSA) determined from 24-hour urine sample collections | % change in 24-hour urinary oxalate excretion between baseline value and value at month 3 | % change in 24-hour urinary oxalate excretion in mg/kg corrected for body surface area (BSA) from baseline to Month 3 and determined from 24-hour urine sample collections |
| Secondary | Absolute change in 24-hour urinary oxalate excretion in mg/kg corrected for body surface area (BSA) from baseline to Month 3 and Month 6 | Absolute change in 24-hour urinary oxalate excretion between baseline value to Month 3 and Month 6 values. | Absolute change in 24-hour urinary oxalate excretion in mg/kg corrected for BSA from baseline to Month 3 and Month 6 |
| Secondary | Change in 24-hour urine oxalate/creatinine ratio from baseline to Month 3 and Month 6 | Change in 24-hour urine oxalate/creatinine ratio between baseline value to month 3 and month 6 values | Concentration of 24-hour urine oxalate and 24-hour urine creatinine will be combined to report urine oxalate/creatinine ratio from baseline to Month 3 and Month 6. The concentrations will be determined using a validated assay |
| Secondary | % of patients with urinary oxalate lower than 1.5 x upper limit of normal (ULN)) at Month 3 and Month 6 | At 3 and 6 months of treatment. | %of patients with near normalisation of 24-hour urinary oxalate level corrected for BSA (defined as urinary oxalate lower than 1.5 x upper limit of normal (ULN)) at Month 3 and Month 6) |
| Secondary | % of patients with normalisation of 24-hour urinary oxalate level corrected for bode surface area at Month 3 and Month 6 | At 3 and 6 months of treatment. | % of patients with near normalisation of 24-hour urinary oxalate level corrected for BSA (defined as urinary oxalate lower than 1.5 x upper limit of normal (ULN)) at Month 3 and Month 6) |
| Secondary | Blood samples for assessment of change in estimated glomerular filtration rate (eGFR in mL/min/1.73m2) from baseline to Month 6 | Change in estimated glomerular filtration rate (eGFR) between baseline value and month 6 value | Blood samples for assessment of change in estimated glomerular filtration rate (eGFR). EGFR (mL/min/1.73m2) will be calculated from baseline to Month 6 |
| Secondary | Occurrence of and frequency of kidney stone events during the follow-up of the patient | From start of participation of the patient to end of the study (Month 60) | Number of and frequency of kidney stone events reported during the follow-up of the patient |
| Secondary | Change in urine oxalate/creatinine ratios as assessed in spot urine collections between baseline and Month 6 | From start of participation of the patient to end of the study (Month 60) | Urine oxalate/creatinine ratios will be calculated from the oxalate and creatinine levels measured in spot urine collected during patients' hospitalizations or at home. The concentrations will be determined using a validated assay. |
| Secondary | Change in biological parameters : oxalate concentration measured in urinary spots collections between baseline and Month 6 | From baseline to 6 months of treatment. | Change in oxalate concentration, related to kidney stone formation, measured in urinary spots collections between baseline and Month 6 |
| Secondary | Change in biological parameters : creatinine concentration measured in urinary spots collections between baseline and Month 6 | From baseline to 6 months of treatment. | Change in creatinine concentration, related to kidney stone formation, measured in urinary spots collections between baseline and Month 6 |
| Secondary | Absolute change in quality of life measured by the Pediatric Quality of Life Inventory (PedsQL) questionnaire | At baseline and every 6 months until the end of the study (Month 60) | Absolute change in the Pediatric Quality of Life Inventory (PedsQL \[the generic and kidney failure (KF) modules\]) for patients \< 18 years of age (at screening) which is a 23 items 5-point Likert scale from: 0 (Never) to 4 (Almost always). Scores are transformed on a scale from 0 to 100 so higher score means better health. |
| Secondary | Absolute change in quality of life measured by the Kidney Disease Quality of Life Questionnaire (KDQOL) | At baseline and every 6 months until the end of the study (Month 60) | Absolute changes in the Kidney Disease Quality of Life Questionnaire (KDQOL) for patients ≥ 18 years of age (at screening) which is a 36 items survey with five subscales. Scores are transformed on a scale from 0 to 100 so higher score means better health. |
| Secondary | Change in quality of life measured by the Euro Quality of Life Health State Profile Questionnaire (EQ-5D) | At baseline and every 6 months until the end of the study (Month 60) | Change in Euro Quality of Life Health State Profile Questionnaire (EQ-5D) is a standardized instrument consisting of a questionnaire. Scoring of the questionnaire is based on degrees of disability. Higher scores indicate better health status. |
| Secondary | Change in quality of life measured by the Euro Quality of Life Health State Profile Visual Analog Scale (VAS) : EQ-5D | At baseline and every 6 months until the end of the study (Month 60) | Change in EQ-5D Visual Analog Scale EQ-5D is a standardized instrument consisting of a visual analog scale pertaining to 5 dimensions. Scoring of the visual analog scale is based on a visual scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate better health status. |
| Other | Height in meters | At baseline and every 3 months until the end of the study (Month 60) | Changes in height in meters |
| Other | Weight in kilograms | At baseline and every 3 months until the end of the study (Month 60) | Changes in weight in kilograms |
| Other | Changes in liver function tests (clinical laboratory parameters) | From start of participation of the patient to the end of the study | Changes in liver function tests (AST, ALT, GGT, ALP, Bilirubin (total and direct)) |
| Other | Complete blood count with differential | At baseline and every months until the end of the study (Month 60) | Changes in complete blood count with differential ( blood test results) |
| Other | Frequency and nature of adverse events | From baseline to the end of the study (Month 60) | Collect of the frequency and nature of adverse events |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06465472/registered