Trial · NCT04152200
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 31 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Absolute Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 60 | Baseline to Month 60 | |
| Secondary | Percent Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 60 | Baseline to Month 60 | |
| Secondary | Change in Quality of Life As Assessed by Pediatric Quality of Life Inventory (PedsQL) Total Score From Baseline to Month 60 in Patients >=2 to 18 Years of Age at Time of Informed Consent | Baseline to Month 60 | Peds-QL is a modular approach to measuring quality of life (QOL) in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Generic Core Scales contain 23 items designed to measure core domains of health (physical, emotional, and social functioning) and role (school functioning). Scores are summarized as Total Scale Score, Physical Health Summary Score, and Psychosocial Health Summary Score. The Total Scale Score will be reported for this study. The PedsQL will be completed by patients (or caregivers, as appropriate) who are ≥2 to \<18 years of age at the time of consent. Total score range: 0 - 100, with higher scores indicating better health-related quality of life (HRQoL). Baseline is defined as last non-missing value collected prior to the first dose of lumasiran. |
| Secondary | Change in Quality of Life As Assessed by Kidney Disease and Quality of Life (KDQOL) Scores From Baseline to Month 60 in Patients ≥18 Years of Age at Time of Informed Consent | Baseline to Month 60 | The KDQOL questionnaire is used to assess 3 core domains of kidney disease including: burden, symptoms/problems, and effects of kidney disease on daily life. The KDQOL subscales (Burden of Kidney Disease, Effect of Kidney Disease on Daily Life, and Symptoms and Problems of Kidney Disease), and the accompanying Short Form-12 (SF-12) Physical Component Summary and Mental Component Summary will be assessed for this study. These will be completed by patients who are ≥18 years of age at the time of consent. Score range (per domain): 0 - 100; higher scores indicate better HRQoL. Baseline is defined as last non-missing value collected prior to the first dose of lumasiran. |
| Secondary | Percent Change in Plasma Oxalate From Baseline to End of Study | Baseline to Month 60 | |
| Secondary | Change in Nephrocalcinosis From Baseline to End of Study | Baseline to Month 60 | Nephrocalcinosis will be assessed by renal ultrasound. |
| Secondary | Change in Frequency of Dialysis From Baseline to End of Study | Baseline to Month 60 | |
| Secondary | Change in Mode of Dialysis From Baseline to End of Study | Baseline to Month 60 | Modes of dialysis are defined as hemodialysis and peritoneal dialysis. |
| Secondary | Change in Frequency of Renal Stone Events From Baseline to End of Study | Baseline to Month 60 | |
| Secondary | Change in Renal Function Assessed by Estimated Glomerular Filtration Rate (eGFR) From Baseline to End of Study | Baseline to Month 60 | |
| Secondary | Change in Measures of Systemic Oxalosis From Baseline to End of Study | Baseline to Month 60 | Systemic oxalosis will be assessed in cardiac, skeletal, ophthalmologic, and dermatologic systems. |
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/registered?page=2