| NCT ID | NCT06986265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Université Catholique de Louvain |
| Condition | Chronic Kidney Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 157 participants |
| Start Date | 2025-02-04 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 157 participants in total. It began in 2025-02-04 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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. 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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Antibiotics consumption in the month preceding the inclusion * Gastro-intestinal surgery, colonoscopy, or probiotics consumption in the 3 months preceding the inclusion * 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
Contact & Investigator
Inès Dufour, MD
PRINCIPAL INVESTIGATOR
Université Catholique de Louvain
Frequently Asked Questions
Who can join the NCT06986265 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06986265 currently recruiting?
Yes, NCT06986265 is actively recruiting participants. Contact the research team at laure.bindels@uclouvain.be for enrollment information.
Where is the NCT06986265 trial being conducted?
This trial is being conducted at Brussels, Belgium, Brussels, Belgium.
Who is sponsoring the NCT06986265 clinical trial?
NCT06986265 is sponsored by Université Catholique de Louvain. The principal investigator is Inès Dufour, MD at Université Catholique de Louvain. The trial plans to enroll 157 participants.
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