Trial · NCT07906405
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Prevalence of GLIM-defined malnutrition | At inclusion (baseline) | Proportion of participants with malnutrition according to the Global Leadership Initiative on Malnutrition (GLIM) criteria (at least one phenotypic criterion: weight loss, low body mass index or reduced muscle mass; and at least one etiologic criterion: reduced food intake or assimilation, or disease burden/inflammation), with severity graded as stage 1 (moderate) or stage 2 (severe). Estimated with 95% confidence interval accounting for clustering by center, overall and by CKD stage and treatment modality. |
| Primary | Prevalence of EWGSOP2-defined sarcopenia | At inclusion (baseline) | Proportion of participants with sarcopenia according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria: reduced muscle strength (five-times sit-to-stand test \> 15 s) with low appendicular skeletal muscle mass index by bioelectrical impedance analysis (\< 7.0 kg/m² in men, \< 5.5 kg/m² in women); severe sarcopenia if gait speed ≤ 0.8 m/s. Estimated with 95% confidence interval accounting for clustering by center, overall and by CKD stage and treatment modality. |
| Secondary | Overlap between malnutrition and sarcopenia | At inclusion (baseline) | Proportion of participants in each of four mutually exclusive phenotypes: neither condition, malnutrition alone, sarcopenia alone, and combined malnutrition and sarcopenia. Agreement between GLIM and EWGSOP2 classifications assessed with Cohen's kappa. |
| Secondary | Malnutrition-Inflammation Score (MIS) | At inclusion (baseline) and at 2 years | Total MIS (10 components, each scored 0 to 3; total range 0 to 30, higher scores indicating greater severity of the malnutrition-inflammation complex), described overall and compared across nutritional and muscle phenotypes. |
| Secondary | Change in malnutrition status between baseline and 2 years | Baseline and 2 years | Proportion of participants with persistence, resolution, new onset or continued absence of GLIM-defined malnutrition between baseline and the 2-year reassessment, among participants reassessed at 2 years. |
| Secondary | Change in sarcopenia status between baseline and 2 years | Baseline and 2 years | Proportion of participants with persistence, resolution, new onset or continued absence of EWGSOP2-defined sarcopenia between baseline and the 2-year reassessment, among participants reassessed at 2 years. |
| Secondary | Initiation of maintenance kidney replacement therapy | Up to 2 years and up to 5 years after inclusion | Time to first initiation of maintenance hemodialysis, maintenance peritoneal dialysis or kidney transplantation, among participants not receiving dialysis at baseline, according to baseline malnutrition and sarcopenia status. Death is considered a competing event. |
| Secondary | All-cause mortality | Up to 2 years and up to 5 years after inclusion | Time to death from any cause according to baseline malnutrition and sarcopenia status. |
| Secondary | Major adverse cardiovascular events (MACE) | Up to 2 years and up to 5 years after inclusion | Time to first MACE, defined as a composite of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, confirmed by medical records, according to baseline malnutrition and sarcopenia status. Non-cardiovascular death is considered a competing event. |
| Other | Sustained decline in eGFR of at least 40% | At 2 years and at 5 years after inclusion | Decline of at least 40% in estimated glomerular filtration rate (CKD-EPI 2021 creatinine equation) from baseline, confirmed by a subsequent measurement when available, among participants not receiving dialysis at baseline. |
| Other | Hospitalizations | From inclusion up to 2 years and from 2 to 5 years | Number of hospitalizations per participant during each follow-up interval, with dates of admission and discharge and principal reason. |
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.
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