MalnutritionTUN-CKDNNCT07906405
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
An observational study of Malnutrition and Sarcopenia, run by Dacima Consulting at 1 site in Tunisia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Sarcopenia, Renal Insufficiency, Chronic
- What is being tested?
- Standardized nutritional and muscle assessment
- How many people
- 4,000 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Nov 2026to 30 Sep 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age 18 years or older.
- Chronic kidney disease known for at least 3 months.
- Chronic kidney disease stage G3a, G3b, G4, G5 not receiving dialysis, or G5D (maintenance hemodialysis or peritoneal dialysis).
- Followed at one of the participating centers.
- Signed informed consent.
Who cannot join
- Kidney transplant recipient.
- Severe acute clinical condition requiring hospitalization at the time of inclusion.
- Inability to provide informed consent.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site
Hôpital Militaire Principal d'Instruction de Tunis, Department of Nephrology
Tunis
Jannet Labidi, MD, +216 98 902 575, jannetlabidi4@gmail.com
About this study
Official title: Nutritional Status, Muscle Phenotype, and Clinical Outcomes in Tunisian Patients With Chronic Kidney Disease: a National Multicenter Prospective Cohort Study (TUN-CKDN)
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.
Read more
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.
Read the detailed description
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).
- Conditions
- Malnutrition, Sarcopenia, Renal Insufficiency, Chronic
- Being tested
- Standardized nutritional and muscle assessment
- Keywords
- GLIM criteria, EWGSOP2, Malnutrition-Inflammation Score, Protein-energy wasting, Body composition, Bioelectrical impedance analysis, Muscle strength, Hemodialysis, Peritoneal dialysis, Kidney replacement therapy, Major adverse cardiovascular events, Mortality, Prospective cohort, Tunisia
- Medical subject headings
- Malnutrition, Sarcopenia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized nutritional and muscle assessmentOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Non-dialysis CKD (stages G3a to G5) | 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. Receives: Other: Standardized nutritional and muscle assessment | |
| Maintenance hemodialysis (stage G5D) | 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. Receives: Other: Standardized nutritional and muscle assessment | |
| Peritoneal dialysis (stage G5D) | 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. Receives: Other: Standardized nutritional and muscle assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At inclusion (baseline)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years and up to 5 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dacima Consulting
- Sponsor type
- University, hospital or other
- Collaborators
- Tunisian Society for Nephrology, Dialysis and Renal Transplantation
- Responsible party
- Sponsor
- Investigators
- Jannet Labidi, MD, Study chair, Hôpital Militaire Principal d'Instruction de TunisLabidi Jannet, MD, Principal investigator, Hôpital Militaire Principal d'Instruction de Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906405
- Sponsor's protocol ID
- DAC-018-TUNCKDN
- Acronym
- TUN-CKDN
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Thanh Hai MT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. J Am Coll Cardiol. 2018 Mar 6;71(9):1021-1034. doi: 10.1016/j.jacc.2017.12.048.
PubMed 29495982Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. No abstract available.
PubMed 38490803Inker LA, Eneanya ND, Coresh J, Tighiouart H, Wang D, Sang Y, Crews DC, Doria A, Estrella MM, Froissart M, Grams ME, Greene T, Grubb A, Gudnason V, Gutierrez OM, Kalil R, Karger AB, Mauer M, Navis G, Nelson RG, Poggio ED, Rodby R, Rossing P, Rule AD, Selvin E, Seegmiller JC, Shlipak MG, Torres VE, Yang W, Ballew SH, Couture SJ, Powe NR, Levey AS; Chronic Kidney Disease Epidemiology Collaboration. New Creatinine- and Cystatin C-Based Equations to Estimate GFR without Race. N Engl J Med. 2021 Nov 4;385(19):1737-1749. doi: 10.1056/NEJMoa2102953. Epub 2021 Sep 23.
PubMed 34554658Ikizler TA, Burrowes JD, Byham-Gray LD, Campbell KL, Carrero JJ, Chan W, Fouque D, Friedman AN, Ghaddar S, Goldstein-Fuchs DJ, Kaysen GA, Kopple JD, Teta D, Yee-Moon Wang A, Cuppari L. KDOQI Clinical Practice Guideline for Nutrition in CKD: 2020 Update. Am J Kidney Dis. 2020 Sep;76(3 Suppl 1):S1-S107. doi: 10.1053/j.ajkd.2020.05.006.
PubMed 32829751Silva MZC, Cederholm T, Gonzalez MC, Lindholm B, Avesani CM. GLIM in chronic kidney disease: What do we need to know? Clin Nutr. 2023 Jun;42(6):937-943. doi: 10.1016/j.clnu.2023.04.019. Epub 2023 Apr 17.
PubMed 37099985Kalantar-Zadeh K, Kopple JD, Block G, Humphreys MH. A malnutrition-inflammation score is correlated with morbidity and mortality in maintenance hemodialysis patients. Am J Kidney Dis. 2001 Dec;38(6):1251-63. doi: 10.1053/ajkd.2001.29222.
PubMed 11728958Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372Jensen GL, Cederholm T, Correia MITD, Gonzalez MC, Fukushima R, Pisprasert V, Blaauw R, Braz DC, Carrasco F, Cruz Jentoft AJ, Cuerda C, Evans DC, Fuchs-Tarlovsky V, Gramlich L, Shi HP, Hasse JM, Hiesmayr M, Hiki N, Jager-Wittenaar H, Jahit S, Jaquez A, Keller H, Klek S, Malone A, Mogensen KM, Mori N, Mundi M, Muscaritoli M, Ng D, Nyulasi I, Pirlich M, Schneider S, de van der Schueren M, Siltharm S, Singer P, Steiber A, Tappenden KA, Yu J, van Gossum A, Wang JY, Winkler MF, Compher C, Barazzoni R. GLIM consensus approach to diagnosis of malnutrition: A 5-year update. JPEN J Parenter Enteral Nutr. 2025 May;49(4):414-427. doi: 10.1002/jpen.2756. Epub 2025 Apr 14.
PubMed 40223699Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.
PubMed 30181091
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status, Muscle Phenotype, and Clinical Outcomes in Tunisian Patients With Chronic Kidney Disease: a National Multicenter Prospective Cohort Study (TUN-CKDN)
- ClinicalTrials.gov ID
- NCT07906405
- Acronym / sponsor ID
- TUN-CKDN / DAC-018-TUNCKDN
- Conditions
- Malnutrition, Sarcopenia, Renal Insufficiency, Chronic
- Keywords
- GLIM criteria, EWGSOP2, Malnutrition-Inflammation Score, Protein-energy wasting, Body composition, Bioelectrical impedance analysis, Muscle strength, Hemodialysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Tunisian Society for Nephrology, Dialysis and Renal Transplantation
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-dialysis CKD (stages G3a to G5) | – | Other: Standardized nutritional and muscle assessmentAdults 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. |
| Maintenance hemodialysis (stage G5D) | – | Other: Standardized nutritional and muscle assessmentAdults 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. |
| Peritoneal dialysis (stage G5D) | – | Other: Standardized nutritional and muscle assessmentAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Chronic kidney disease known for at least 3 months.
- Chronic kidney disease stage G3a, G3b, G4, G5 not receiving dialysis, or G5D (maintenance hemodialysis or peritoneal dialysis).
- Followed at one of the participating centers.
- Signed informed consent.
Key exclusion criteria (4 listed)
- Kidney transplant recipient.
- Severe acute clinical condition requiring hospitalization at the time of inclusion.
- Inability to provide informed consent.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized nutritional and muscle assessmentNo 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). | Other | Maintenance hemodialysis (stage G5D), Non-dialysis CKD (stages G3a to G5), Peritoneal dialysis (stage G5D) |
Primary outcome
Prevalence of GLIM-defined malnutrition
Time frame: 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.
Prevalence of EWGSOP2-defined sarcopenia
Time frame: 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.
7 secondary outcomes
Overlap between malnutrition and sarcopenia
Time frame: At inclusion (baseline)
Malnutrition-Inflammation Score (MIS)
Time frame: At inclusion (baseline) and at 2 years
Change in malnutrition status between baseline and 2 years
Time frame: Baseline and 2 years
Change in sarcopenia status between baseline and 2 years
Time frame: Baseline and 2 years
Initiation of maintenance kidney replacement therapy
Time frame: Up to 2 years and up to 5 years after inclusion
All-cause mortality
Time frame: Up to 2 years and up to 5 years after inclusion
Major adverse cardiovascular events (MACE)
Time frame: Up to 2 years and up to 5 years after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 29495982Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Thanh Hai MT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. J Am Coll Cardiol. 2018 Mar 6;71(9):1021-1034. doi: 10.1016/j.jacc.2017.12.048.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 38490803Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. No abstract available.
- Background: PubMed 34554658Inker LA, Eneanya ND, Coresh J, Tighiouart H, Wang D, Sang Y, Crews DC, Doria A, Estrella MM, Froissart M, Grams ME, Greene T, Grubb A, Gudnason V, Gutierrez OM, Kalil R, Karger AB, Mauer M, Navis G, Nelson RG, Poggio ED, Rodby R, Rossing P, Rule AD, Selvin E, Seegmiller JC, Shlipak MG, Torres VE, Yang W, Ballew SH, Couture SJ, Powe NR, Levey AS; Chronic Kidney Disease Epidemiology Collaboration. New Creatinine- and Cystatin C-Based Equations to Estimate GFR without Race. N Engl J Med. 2021 Nov 4;385(19):1737-1749. doi: 10.1056/NEJMoa2102953. Epub 2021 Sep 23.
- Background: PubMed 32829751Ikizler TA, Burrowes JD, Byham-Gray LD, Campbell KL, Carrero JJ, Chan W, Fouque D, Friedman AN, Ghaddar S, Goldstein-Fuchs DJ, Kaysen GA, Kopple JD, Teta D, Yee-Moon Wang A, Cuppari L. KDOQI Clinical Practice Guideline for Nutrition in CKD: 2020 Update. Am J Kidney Dis. 2020 Sep;76(3 Suppl 1):S1-S107. doi: 10.1053/j.ajkd.2020.05.006.
- Background: PubMed 37099985Silva MZC, Cederholm T, Gonzalez MC, Lindholm B, Avesani CM. GLIM in chronic kidney disease: What do we need to know? Clin Nutr. 2023 Jun;42(6):937-943. doi: 10.1016/j.clnu.2023.04.019. Epub 2023 Apr 17.
- Background: PubMed 11728958Kalantar-Zadeh K, Kopple JD, Block G, Humphreys MH. A malnutrition-inflammation score is correlated with morbidity and mortality in maintenance hemodialysis patients. Am J Kidney Dis. 2001 Dec;38(6):1251-63. doi: 10.1053/ajkd.2001.29222.
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Background: PubMed 40223699Jensen GL, Cederholm T, Correia MITD, Gonzalez MC, Fukushima R, Pisprasert V, Blaauw R, Braz DC, Carrasco F, Cruz Jentoft AJ, Cuerda C, Evans DC, Fuchs-Tarlovsky V, Gramlich L, Shi HP, Hasse JM, Hiesmayr M, Hiki N, Jager-Wittenaar H, Jahit S, Jaquez A, Keller H, Klek S, Malone A, Mogensen KM, Mori N, Mundi M, Muscaritoli M, Ng D, Nyulasi I, Pirlich M, Schneider S, de van der Schueren M, Siltharm S, Singer P, Steiber A, Tappenden KA, Yu J, van Gossum A, Wang JY, Winkler MF, Compher C, Barazzoni R. GLIM consensus approach to diagnosis of malnutrition: A 5-year update. JPEN J Parenter Enteral Nutr. 2025 May;49(4):414-427. doi: 10.1002/jpen.2756. Epub 2025 Apr 14.
- Background: PubMed 30181091Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.
- Individual participant dataSharing planned: 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.
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jannet Labidi, MD study chair
Hôpital Militaire Principal d'Instruction de Tunis
Labidi Jannet, MD principal investigator
Hôpital Militaire Principal d'Instruction de Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Sarcopenia, run by Dacima Consulting at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jannet Labidi, MD (+216 98 902 575, jannetlabidi4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of GLIM-defined malnutrition (time frame: At inclusion (baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07906405, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.