Chronic Kidney DiseasesDYNAMICANCT06986265
CKD Cachexia and Gut Microbiome
An observational study of Chronic Kidney Diseases and Cachexia, run by Université Catholique de Louvain at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Cachexia
- What is being tested?
- Collection of clinical data and biological sampling
- How many people
- 157 participants
- Where
- 2 sitesBelgium
- Study dates
- 4 Feb 2025to Dec 2030
- 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Inès Dufour, MD, 003227641855, ines.dufour@saintluc.uclouvain.be
Eric Goffin, MD, 003227641855, eric.goffin@saintluc.uclouvain.be
- Not yet recruiting
UCLouvain
Brussels, 1200
Laure Bindels, PhD, +32 (2) 764 73 37, laure.bindels@uclouvain.be
Eric Goffin, MD, +32(2)764 18 55, eric.goffin@saintluc.uclouvain.be
About this study
Official title: Association of Cachexia and Gut Microbiome in Dialysis Patients : Investigation of the Interactions With Uremic Toxins and Inflammation.
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:
- 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.
- 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
- Being tested
- Collection of clinical data and biological sampling
- Keywords
- cachexia, Protein energy wasting, microbiota, chronic kidney disease, dialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of clinical data and biological samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dialysis patients | Collection of clinical data and biological samples Receives: Other: Collection of clinical data and biological sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition and function of the gut microbiota
Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition and function
Measured: Throughout the entire study, approximately during 5 years
Secondary outcomes (11)
Level of inflammatory markers
Measured: Throughout the entire study, approximately during 5 years
Level of uremic toxins
Measured: Throughout the entire study, approximately during 5 years
Metabolomics profile
Measured: Throughout the entire study, approximately during 5 years
Dialysis dose
number of hours of dialysis per week
Measured: Throughout the entire study, approximately during 5 years
Dialysis modality
in-center hemodialysis vs self-care dialysis in a satellite unit vs home-hemodialysis vs peritoneal dialysis
Measured: Throughout the entire study, approximately during 5 years
Body composition
Bioelectrical impedance analysis (in kg)
Measured: Throughout the entire study, approximately during 5 years
Body composition
Noncontrast enhanced CT scan of the abdomen at the level of the third lumbar vertebra (L3)
Measured: Throughout the entire study, approximately during 5 years
Quality of life
FAACT (Functional Assessment of Anorexia-Cachexia Therapy) and FACIT (Functional Assessment of Chronic Illness Therapy - Fatigue Scale) questionnaires
Measured: Throughout the entire study, approximately during 5 years
Handgrip strength
Jamar dynamometer (in kg)
Measured: Throughout the entire study, approximately during 5 years
Physical activity
International Physical Activity Questionnaire (IPAQ)
Measured: Throughout the entire study, approximately during 5 years
Appetite
Simplified Nutritional Assessment Questionnaire (SNAQ).
Measured: Throughout the entire study, approximately during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start4 Feb 2025
- Primary completionJan 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique, FRC- Fonds de la Recherche Clinique, SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation
- Responsible party
- Sponsor
- Investigators
- Inès Dufour, MD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986265
- Sponsor's protocol ID
- B403202400099
- Acronym
- DYNAMICA
- Status last verified
- May 2025
- First submitted
- 5 Dec 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Cachexia and Gut Microbiome in Dialysis Patients : Investigation of the Interactions With Uremic Toxins and Inflammation.
- ClinicalTrials.gov ID
- NCT06986265
- Acronym / sponsor ID
- DYNAMICA / B403202400099
- Conditions
- Chronic Kidney Diseases, Cachexia
- Keywords
- cachexia, Protein energy wasting, microbiota, chronic kidney disease, dialysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique, FRC- Fonds de la Recherche Clinique, SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 22 May 2025 (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.
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:
- 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.
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialysis patients | – | Other: Collection of clinical data and biological samplingCollection of clinical data and biological samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Collection of clinical data and biological samplingMultiple 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. | Other | Dialysis patients |
Primary outcome
Composition and function of the gut microbiota
Time frame: Throughout the entire study, approximately during 5 years
Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition and function
11 secondary outcomes
Level of inflammatory markers
Time frame: Throughout the entire study, approximately during 5 years
Level of uremic toxins
Time frame: Throughout the entire study, approximately during 5 years
Metabolomics profile
Time frame: Throughout the entire study, approximately during 5 years
Dialysis dose
Time frame: Throughout the entire study, approximately during 5 years
Dialysis modality
Time frame: Throughout the entire study, approximately during 5 years
Body composition
Time frame: Throughout the entire study, approximately during 5 years
Body composition
Time frame: Throughout the entire study, approximately during 5 years
Quality of life
Time frame: Throughout the entire study, approximately during 5 years
Handgrip strength
Time frame: Throughout the entire study, approximately during 5 years
Physical activity
Time frame: Throughout the entire study, approximately during 5 years
Appetite
Time frame: Throughout the entire study, approximately during 5 years
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 22 May 2025.
- Individual participant dataSharing planned: No
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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.
Inès Dufour, MD principal investigator
Université Catholique de Louvain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Cachexia, run by Université Catholique de Louvain at 2 sites in Belgium.
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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 Laure Bindels, PhD (+32(2)7647337, laure.bindels@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition and function of the gut microbiota (time frame: Throughout the entire study, approximately during 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2025.