An observational study in Malnutrition, Sarcopenia and Renal Insufficiency, Chronic, sponsored by Dacima Consulting. Not yet recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Dacima Consulting · Observational
The TUN-CKDN study is a national, multicenter, prospective cohort study conducted in nephrology centers in Tunisia. It aims to describe how often malnutrition and sarcopenia (loss of muscle strength and muscle mass) occur in adults with chronic kidney disease (CKD) stages G3a to G5D, including patients not on dialysis and patients treated by hemodialysis or peritoneal dialysis, and whether these conditions are linked to future health outcomes.
At inclusion, each participant will undergo a standardized nutritional and muscle assessment as part of routine care: medical history, physical activity questionnaire, clinical examination, body weight and height, body composition by bioelectrical impedance analysis (or calf circumference when impedance cannot be performed), a chair-stand test for muscle strength, a 4-meter walking speed test, routine blood tests, and a detailed dietary interview conducted by a trained dietitian. Malnutrition will be defined using the Global Leadership Initiative on Malnutrition (GLIM) criteria and sarcopenia using the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria. The Malnutrition-Inflammation Score (MIS) will also be calculated.
Participants available at 2 years will have the same nutritional and muscle assessment repeated. All participants will be followed at 2 and 5 years to record kidney outcomes (start of dialysis or kidney transplantation in patients not on dialysis at inclusion), major cardiovascular events, hospitalizations, and deaths.
The study does not involve any treatment or change in usual medical care. About 4,000 participants are planned.
Background Malnutrition and sarcopenia are frequent and clinically relevant complications of chronic kidney disease (CKD). They are related but distinct conditions. Evidence evaluating GLIM-defined malnutrition and EWGSOP2-defined sarcopenia concurrently remains limited, particularly across both non-dialysis CKD and dialysis populations, and longitudinal data on changes in these phenotypes and their association with kidney, cardiovascular and mortality outcomes are scarce. No multicenter data are available in Tunisia.
Design TUN-CKDN (Tunisian Chronic Kidney Disease Nutrition) is a national, multicenter, prospective, longitudinal cohort study sponsored by the Société Tunisienne de Néphrologie, Dialyse et Transplantation Rénale (STNDT). Eligible patients followed in participating nephrology centers will be consecutively included over a planned 6-month recruitment period. Participants will be followed at 2 and 5 years after inclusion (window of plus or minus 3 months).
Objectives Primary objective: to estimate, at baseline, the prevalence of GLIM-defined malnutrition and EWGSOP2-defined sarcopenia in patients with CKD stages G3a to G5D.
Secondary objectives: (1) to describe the baseline overlap between malnutrition and sarcopenia (isolated and combined phenotypes) and to characterize nutritional and inflammatory status using the Malnutrition-Inflammation Score (MIS); (2) to describe the persistence, resolution and new onset of malnutrition and sarcopenia between baseline and 2 years; (3) to investigate the association of baseline malnutrition and sarcopenia with initiation of maintenance kidney replacement therapy among participants not receiving dialysis at baseline, major adverse cardiovascular events (MACE) and all-cause mortality at 2 and 5 years.
Baseline assessment Data will be collected in a standardized electronic case report form (DACIMA Clinical Suite) and will include: sociodemographic characteristics; medical history, comorbidities and lifestyle factors; physical activity and sitting time (IPAQ-SF); CKD characteristics and treatment, including dialysis modality; clinical assessment of volume status; anthropometry (height, current weight, previous weights at 3 and 6 months and beyond 6 months when available, reference body weight determined according to volume status and dialysis modality); body composition by segmental bioelectrical impedance analysis using the same device model across centers, with calf circumference as an alternative surrogate for GLIM when impedance is unavailable or not interpretable; clinical assessment of subcutaneous fat loss and muscle wasting; muscle strength by the five-times sit-to-stand test (5STS); physical performance by usual gait speed over 4 meters; laboratory parameters from routine care (performed within 7 days of the clinical examination, immediately before a midweek session in hemodialysis patients); dietary intake by standardized dietary history conducted by trained dietitians and analyzed with Nutrilog software using the CIQUAL 2020 food composition table; and nutritional prescriptions.
Definitions Malnutrition will be diagnosed according to the GLIM criteria and their 2025 update (at least one phenotypic and one etiologic criterion) and graded as stage 1 (moderate) or stage 2 (severe). Sarcopenia will be classified according to EWGSOP2 as absent, probable, confirmed or severe, or not classifiable when muscle strength cannot be assessed; confirmation requires low muscle mass by bioelectrical impedance. The MIS (0 to 30) will be calculated as a complementary measure. Derived scores and classifications will be generated automatically in the eCRF according to predefined algorithms. Missing diagnostic data will not be imputed; phenotypes that cannot be determined will be classified as indeterminate.
Follow-up At 2 years, participants alive and available will undergo the same nutritional and muscle reassessment (the detailed dietary survey is not repeated). At 2 and 5 years, vital status, cause of death, MACE (non-fatal myocardial infarction, non-fatal stroke and cardiovascular death), hospitalizations and, in participants not on dialysis at baseline, kidney function (creatinine, eGFR by CKD-EPI 2021, urinary albumin-to-creatinine ratio, KDIGO categories) and initiation of kidney replacement therapy will be recorded. Reported events will be confirmed by review of medical records.
Sample size and analysis A total of 4,000 participants will be included (two-sided alpha 5%, 80% power, design effect 1.5 for clustering by center, 10% non-evaluable participants and 10% loss to follow-up at 5 years). Prevalences will be estimated with 95% confidence intervals accounting for clustering by center. Overlap will be described with four mutually exclusive phenotypes and Cohen's kappa. Changes at 2 years will be described with transition matrices and McNemar's test, weighted by the inverse probability of reassessment. Associations with outcomes will be analyzed with Cox models with shared frailty for center, with competing-risk models (Fine-Gray or cause-specific) for kidney replacement therapy and MACE. Three analyses are planned: cross-sectional at the end of recruitment, at 2 years and at 5 years.
Ethics The study is observational and does not modify usual care. Written informed consent will be obtained from all participants. Data will be pseudonymized and processed in accordance with Tunisian data-protection requirements (INPDP).
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 206 across 393 observational studies indexed under Malnutrition.
Browse Malnutrition studies →Dacima Consulting is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with chronic kidney disease stages G3a to G5D followed in participating nephrology centers in Tunisia, including patients not receiving dialysis and patients treated by maintenance hemodialysis or peritoneal dialysis. Eligible patients are included consecutively during routine nephrology consultations or dialysis sessions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with chronic kidney disease stages G3a, G3b, G4 or G5 not receiving maintenance dialysis at inclusion. Participants undergo a standardized nutritional and muscle assessment at baseline and at 2 years, and are followed at 2 and 5 years for kidney function, initiation of kidney replacement therapy, major adverse cardiovascular events, hospitalizations and mortality.
Other: Standardized nutritional and muscle assessment
Adults with chronic kidney disease stage G5D treated by maintenance hemodialysis at inclusion. Participants undergo a standardized nutritional and muscle assessment at baseline and at 2 years, and are followed at 2 and 5 years for major adverse cardiovascular events, hospitalizations and mortality.
Other: Standardized nutritional and muscle assessment
Adults with chronic kidney disease stage G5D treated by peritoneal dialysis at inclusion. Participants undergo a standardized nutritional and muscle assessment at baseline and at 2 years, and are followed at 2 and 5 years for major adverse cardiovascular events, hospitalizations and mortality.
Other: Standardized nutritional and muscle assessment
No treatment is administered and usual care is not modified. Assessment performed as part of the study: clinical nutritional examination, anthropometry, bioelectrical impedance analysis (or calf circumference when impedance is unavailable), five-times sit-to-stand test, 4-meter gait speed, routine laboratory tests, physical activity questionnaire (IPAQ-SF) and dietary history by a trained dietitian (baseline only).
Prevalence of GLIM-defined malnutrition
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.
Time frame: At inclusion (baseline)
Prevalence of EWGSOP2-defined sarcopenia
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.
Time frame: At inclusion (baseline)
Overlap between malnutrition and sarcopenia
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.
Time frame: At inclusion (baseline)
Malnutrition-Inflammation Score (MIS)
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.
Time frame: At inclusion (baseline) and at 2 years
Change in malnutrition status between 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.
Time frame: Baseline and 2 years
Change in sarcopenia status between 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.
Time frame: Baseline and 2 years
Initiation of maintenance kidney replacement therapy
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.
Time frame: Up to 2 years and up to 5 years after inclusion
All-cause mortality
Time to death from any cause according to baseline malnutrition and sarcopenia status.
Time frame: Up to 2 years and up to 5 years after inclusion
Major adverse cardiovascular events (MACE)
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.
Time frame: Up to 2 years and up to 5 years after inclusion
Sustained decline in eGFR of at least 40%
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.
Time frame: At 2 years and at 5 years after inclusion
Hospitalizations
Number of hospitalizations per participant during each follow-up interval, with dates of admission and discharge and principal reason.
Time frame: From inclusion up to 2 years and from 2 to 5 years
Plan to share: No — Individual participant data will not be made publicly available. According to the protocol, the sponsor (STNDT) retains full authority over the data, access is restricted to authorized study personnel, and data processing is subject to Tunisian data-protection requirements (INPDP). Reasonable requests for aggregated data or collaborative analyses may be submitted to the sponsor's scientific committee and will be assessed on a case-by-case basis.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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