Trial · NCT07906405
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
NCT07906405, Not yet recruiting, Dacima Consulting
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia. Trials, record NCT07906405. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07906405
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
- NCT number
- NCT07906405
- Status
- Not yet recruiting
- Enrollment
- 4,000 participants, estimated
- Lead sponsor
- Dacima Consulting
- Conditions
- Malnutrition, Sarcopenia, Renal Insufficiency, Chronic
- Interventions
- Standardized nutritional and muscle assessment
- First posted
- 2026-10-30
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07906405
GET https://conductscience.org/api/trials/v1/NCT07906405/registered