CKD Cachexia and Gut Microbiome

NCT06986265 | Recruiting

• 1 other identifier: B403202400099
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 2

Brief Summary

Cachexia is common in patients with chronic kidney disease (CKD) and is associated with increased morbidity and mortality. Cachexia is a complex syndrome, in which inflammation and retention of uremic toxins are two main contributing factors. In this context, the role of the gut microbiome in CKD cachexia and the potential benefit of increasing the dialysis dose have been poorly explored. Here the investigators propose to study the links between cachexia and the gut microbiome, in association with inflammation and uremic toxins, in dialysis. The specific objectives are the followings:

1. 1.Set up a prospective cohort of deeply characterized kidney failure patients treated with hemodialysis (in-center, self-care dialysis in a satellite unit and at home) and peritoneal dialysis, including evaluation of cachexia, body composition, collection of feces and blood to characterize the gut microbiota, measure serum levels of uremic toxins and inflammatory markers, with a longitudinal follow-up.
2. 2.To compare cachectic versus non-cachectic dialysis patients in terms of gut microbiota, inflammatory markers, level of uremic toxins, muscle transcriptome, dialysis dose and modality. In a subgroup analysis, the investigators plan to compare the different techniques of dialysis (in-center vs home-hemodialysis vs peritoneal dialysis).

Conditions

Chronic Kidney Diseases; Cachexia

Keywords

cachexia; Protein energy wasting; microbiota; chronic kidney disease; dialysis

Outcome Measures

Primary Outcomes (1)

• Composition and function of the gut microbiota

  Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition and function

  Throughout the entire study, approximately during 5 years

Secondary Outcomes (11)

• Level of inflammatory markers

  Throughout the entire study, approximately during 5 years

• Level of uremic toxins

  Throughout the entire study, approximately during 5 years

• Metabolomics profile

  Throughout the entire study, approximately during 5 years

• Dialysis dose

  Throughout the entire study, approximately during 5 years

• Dialysis modality

  Throughout the entire study, approximately during 5 years

Study Arms (1)

Dialysis patients

Collection of clinical data and biological samples

Other: Collection of clinical data and biological sampling

Interventions

Collection of clinical data and biological sampling OTHER

Multiple measures relevant to cachexia, such as body weight, body mass index (BMI), muscle mass (handgrip strength using a Jamar hand dynamometer, mid-upper arm muscle circumference), appetite (Functional Assessment of Anorexia/Cachexia Therapy \[FAACT\], Simplified Nutritional Appetite Questionnaire \[SNAQ\], Automated Self- Administered Dietary Assessment Tool \[ASA24\]) will be recorded at inclusion (T0), after 6 months (T6) and after one year of follow-up (T12). Body composition will be assessed by bioelectrical impedance analysis at T0, T6 and T12, and by CT-scan at T0 and T12. In parallel, gut microbiota composition on feces collection will be determined at the two time points (T0 and T12). Markers of systemic and intestinal inflammation will be assessed at T0 and T12. Serum levels of uremic toxins will be measured at T0 and T12. Human muscle biopsies will be performed at the time of a surgical intervention.

Dialysis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient population studied is adult kidney failure patients treated with hemodialysis (in-center, self-care dialysis in a satellite unit or at home) or with peritoneal dialysis for more than 3 months. The principal investigator, who is a Nephrologist and works at the Nephrology Department, in Cliniques universitaires Saint-Luc, in contact with dialysis patients, will check patient eligibility, collect the consent from the subjects who agree to participate and allocate an ID number.

You may qualify if:

• Age ≥ 18 years
• Diagnosis of kidney failure (stage V)
• Maintenance dialysis for at least 3 months
• Understanding of the trial procedures and ability to adhere to the trial protocol

You may not qualify if:

• Severe nonadherence to the dialysis procedure
• Life expectancy below 1 year
• Chronic inflammatory disease of the digestive tract (Crohn's disease, ulcerative colitis)
• Bariatric surgery
• Active cancer
• Pregnancy
• Drugs influencing body composition initiated ≤ 1 month : systemic corticosteroids, anabolic drugs as insulin or testosterone, post-menopausal hormone therapy, injectable contraceptives.
• Known endocrinological disorders potentially leading to hypo- or hypermetabolism, untreated or treated for ≤ 1 month : disorders of thyroid gland, adrenal glands...
• Patients under weight loss drugs : GLP1 agonists, orlistat

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• Fonds National de la Recherche Scientifique: collaborator
• FRC- Fonds de la Recherche Clinique: collaborator
• SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation: collaborator

Study Sites (2)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

UCLouvain

Brussels, 1200, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cachexia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness

Study Officials

• Inès Dufour, MD

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure Bindels, PhD

CONTACT

+32(2)7647337; laure.bindels@uclouvain.be

Eric Goffin, MD

CONTACT

+32(2)7641855; eric.goffin@saintluc.uclouvain.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: May 22, 2025
• Study Start: February 4, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)