Chronic Kidney DiseasesRENAMUS 19NCT04896047
FGF19 and Chronic Kidney Disease
A study testing Meal test and muscle biopsies in people with Chronic Kidney Diseases, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Sarcopenia in chronic kidney disease (CKD) affects 50% of dialysis patients and 20% of patients with non-dialyzed CKD and reduce quality of life and survival. The pathophysiology of uremic sarcopenia is multifactorial (accumulation of toxins, metabolic disturbances, etc.) and poorly characterized. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Meal test and muscle biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2022to 6 Feb 2027
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -For the patient population:
- estimated GFR <60 ml / min / 1.73m2 according to the CKD-EPI formula OR patients dialyzed for more than 3 months
- No history of kidney transplant
- BMI between 18 and 30 kg / m²
- For women of childbearing age, at least one method of contraception recognized as effective
- Willing and able to give informed consent
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- For control group:
- Potential living kidney donor
- Willing and able to give informed consent
- For all of the study participants:
- o Non diabetic (fasting blood glucose <1.26 g / L, or absence of insulin or oral antidiabetic treatment)
Who cannot join
- For the patient population:
- Subjects with a history of colectomy, gut resection or cholecystectomy
- Having received antibiotics, prebiotics, probiotics in the last 3 months.
- Taking a high dose laxative treatment (> 2 doses per day) in the last 3 months
- Hemoglobin <7 g / dl or <9 g / L in case of previous cardiovascular disease
- For control group:
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- DFGe ≤ 80 ml / min / 1.73m2 according to CKD-EPI
- High blood pressure (PA≥140 / 90 mmHg) or taking antihypertensive treatment
- Presence of proteinuria (> 0.15 g / 24h) or micro-albuminuria (> 3 mg / mg creatinuria) or hematuria (> 20 GR / mm3)
- For all of the study participants:
- Hemoglobin <7 g / dl or <9 g / L in case of previous cardiovascular disease
- Active inflammatory, infectious, cardiovascular or neoplastic disease
- Period of exclusion from a previous study or already participating in a clinical research protocol having an impact on the study judgment criteria
- Exposure to ionizing radiation (medical radiological examinations or occupational exposure with exposure greater than 20 mSv) in the 6 months preceding inclusion
- No affiliation to social security
- Patient under guardianship or safeguarding justice
- Pregnant patient (a pregnancy test will be carried out for women of reproductive age o For the patients and control group will accept muscles biopsies
- Presence of a precarious venous capital that does not allow the placement of a venous catheter - Thrombocytopenia
- History of arrhythmias or cardiac conduction disorders
- Taking anticoagulant and / or antiplatelet agent
- Pulse <50 bpm
- Allergy to local anesthetics and / or plaster
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Lyon SUD
Pierre-Bénite, 69310
Laetitia KOPPE, PhD, 04 72 67 87 15 ext. +33, laetitia.koppe@chu-lyon.fr
About this study
Official title: Role of FGF19 in Sarcopenia Associated with Chronic Kidney Disease
Sarcopenia in chronic kidney disease (CKD) affects 50% of dialysis patients and 20% of patients with non-dialyzed CKD and reduce quality of life and survival. The pathophysiology of uremic sarcopenia is multifactorial (accumulation of toxins, metabolic disturbances, etc.) and poorly characterized. These pejorative factors are associated with malnutrition and a sedentary lifestyle. Currently, there are no strategies to combat sarcopenia with the exception of physical activity, which is only possible for a limited number of patients due to their comorbidities. Developing new pharmacological strategies to combat sarcopenia is necessary.
FGF19 is a growth factor produced in the ileum involved in metabolic homeostasis. In the laboratory, a new function of FGF19 has been discovered. FGF19 acts as a hormonal factor stimulating muscle mass and strength. Preliminary studies had shown a decrease in the concentration and secretion of FGF19 in response to a meal in haemodialysis patients. However, the link between FGF19, muscle mass and CKD has never been demonstrated. The aim of this study is to assess the relationship between the concentration and secretion of FGF19 and muscle function in a large population of patients with CKD of different stages. Given the hormonal communication between the bone and the muscle, the investigators will also recover the bone histological parameters from a bone biopsy if dialysis patients are to benefit from this as part of their follow-up.
The investigators hypothesize that a decrease in FGF19 concentration and secretion in CKD is associated with a decrease in muscle mass and strength.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Meal test and muscle biopsies
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal test and muscle biopsiesProcedure or surgery
The FGF19 parameters will be assessed in fasting and in postprandial period after the consumption of a hyper-carbohydrate and hyper-lipidic test meal called Flexmeal.
A muscle biopsies by a needle will be performed before and after the Flexmeal.
| Study group | Role | What they receive |
|---|---|---|
| CKD patients | Experimental | Patients with CKD, non-diabetic, without a history of renal transplantation, without digestive pathology, aged 18 to 70 and an estimate of the glomerular filtration rate (eGFR) <60 ml / min / 1.73m2 according to the formula of CKD-EPI. Receives: Procedure: Meal test and muscle biopsies |
| Haemodialysis patients | Active comparator | Patients on hemodialysis, for more than 3 months, with no history of kidney transplantation, without digestive pathology, aged 18 to 70 with a BMI between 18 and 30 kg / m2 Receives: Procedure: Meal test and muscle biopsies |
| Healthy volunteers | Active comparator | Healthy volunteers (controls) recruited from the population of living kidney donors or among patients from the nephrology department whose check-up shows no renal pathology Receives: Procedure: Meal test and muscle biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the fasting plasma concentration of FGF19 and the muscle mass
Study the correlation between the fasting plasma concentration of FGF19 and the muscle mass in % of body weight, measured by DEXA scanner (Dual-X-Ray-Absorptiometry) in non-dialyzed MRC patients with a measured glomerular filtration rate (mDFG) <60 ml / min /1.73m², hemodialysis patients and healthy voluntary being assessed for a kidney donation or a nephrological check-up with no renal pathology..
Measured: At the end of the study (55 months)
Secondary outcomes (10)
Correlation between fasting plasma FGF19 concentration and Glomerular Filtration Rate (GFR)
Correlation between fasting plasma FGF19 concentration and Glomerular Filtration Rate (GFR) measured by a reference method (Iohexol clearance or Tc DTPA) for non-dialysis patients (in ml/min/1.73m2)
Measured: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and muscle strength
Correlation between fasting plasma FGF19 concentration and muscle strength in kilograms in the Hand Grip
Measured: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and muscle performance
Correlation between fasting plasma FGF19 concentration and muscle performance assessed by the 6-minute walk test (TM6) evaluated in metres and by the SPPB (Short Physical Performance Battery) test with a score between 0 and 12
Measured: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and muscle quality
Correlation between fasting plasma FGF19 concentration and muscle quality assessed by ultrasound (echogenicity intensity (EI) from 0 for black to 255 white and qualitatively by the Heckmatt visual assessment scale (Grade I to IV)).
Measured: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and muscle mass
Correlation between fasting plasma FGF19 concentration and muscle mass obtained by ultrasound by measuring the cross-sectional area (in mm2) of the rectus femoris muscle (RF-CSA, Rectus femoris anatomical cross-sectional area)
Measured: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and bone density
Correlation between fasting plasma FGF19 concentration and bone density determined by DEXA scan (total T-score)
Measured: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and bone quality in dialysis patients
Correlation between fasting plasma FGF19 concentration and bone quality in dialysis patients as assessed by the level of bone remodelling determined on bone biopsy (BFR/BS)
Measured: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and physical activity
Correlation between fasting plasma FGF19 concentration and physical activity assessed by the STAQ questionnaire (in hours/week) only if the primary endpoint is significant.
Measured: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and faecal bacterial microbiological profile
Correlation between fasting plasma FGF19 concentration and faecal bacterial microbiological profile by 16s sequencing of stool samples (analysis performed in a second step)
Measured: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and the number of adverse events
Correlation between fasting plasma FGF19 concentration and the number of adverse events such as mortality, cardiovascular events and fractures throughout the protocol
Measured: At the end of the study (55 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start6 Jul 2022
- Primary completion6 Feb 2027 (estimated)
- Study completion6 Feb 2027 (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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896047
- Sponsor's protocol ID
- 69HCL19_0823
- Acronym
- RENAMUS 19
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2021
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of FGF19 in Sarcopenia Associated with Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04896047
- Acronym / sponsor ID
- RENAMUS 19 / 69HCL19_0823
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 6 Feb 2027 (estimated)
- Study completion
- 6 Feb 2027 (estimated)
- First posted
- 21 May 2021 (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.
Sarcopenia in chronic kidney disease (CKD) affects 50% of dialysis patients and 20% of patients with non-dialyzed CKD and reduce quality of life and survival. The pathophysiology of uremic sarcopenia is multifactorial (accumulation of toxins, metabolic disturbances, etc.) and poorly characterized. These pejorative factors are associated with malnutrition and a sedentary lifestyle. Currently, there are no strategies to combat sarcopenia with the exception of physical activity, which is only possible for a limited number of patients due to their comorbidities. Developing new pharmacological strategies to combat sarcopenia is necessary.
FGF19 is a growth factor produced in the ileum involved in metabolic homeostasis. In the laboratory, a new function of FGF19 has been discovered. FGF19 acts as a hormonal factor stimulating muscle mass and strength. Preliminary studies had shown a decrease in the concentration and secretion of FGF19 in response to a meal in haemodialysis patients. However, the link between FGF19, muscle mass and CKD has never been demonstrated. The aim of this study is to assess the relationship between the concentration and secretion of FGF19 and muscle function in a large population of patients with CKD of different stages. Given the hormonal communication between the bone and the muscle, the investigators will also recover the bone histological parameters from a bone biopsy if dialysis patients are to benefit from this as part of their follow-up.
The investigators hypothesize that a decrease in FGF19 concentration and secretion in CKD is associated with a decrease in muscle mass and strength.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD patients | Experimental | Procedure: Meal test and muscle biopsiesPatients with CKD, non-diabetic, without a history of renal transplantation, without digestive pathology, aged 18 to 70 and an estimate of the glomerular filtration rate (eGFR) <60 ml / min / 1.73m2 according to the formula of CKD-EPI. |
| Haemodialysis patients | Active comparator | Procedure: Meal test and muscle biopsiesPatients on hemodialysis, for more than 3 months, with no history of kidney transplantation, without digestive pathology, aged 18 to 70 with a BMI between 18 and 30 kg / m2 |
| Healthy volunteers | Active comparator | Procedure: Meal test and muscle biopsiesHealthy volunteers (controls) recruited from the population of living kidney donors or among patients from the nephrology department whose check-up shows no renal pathology |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- estimated GFR <60 ml / min / 1.73m2 according to the CKD-EPI formula OR patients dialyzed for more than 3 months
- No history of kidney transplant
- BMI between 18 and 30 kg / m²
- For women of childbearing age, at least one method of contraception recognized as effective
- Willing and able to give informed consent
Key exclusion criteria (22 listed)
- For the patient population:
- For control group:
- For all of the study participants:
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 |
|---|---|---|
| Meal test and muscle biopsiesThe FGF19 parameters will be assessed in fasting and in postprandial period after the consumption of a hyper-carbohydrate and hyper-lipidic test meal called Flexmeal. A muscle biopsies by a needle will be performed before and after the Flexmeal. | Procedure or surgery | CKD patients, Haemodialysis patients, Healthy volunteers |
Primary outcome
Correlation between the fasting plasma concentration of FGF19 and the muscle mass
Time frame: At the end of the study (55 months)
Study the correlation between the fasting plasma concentration of FGF19 and the muscle mass in % of body weight, measured by DEXA scanner (Dual-X-Ray-Absorptiometry) in non-dialyzed MRC patients with a measured glomerular filtration rate (mDFG) <60 ml / min /1.73m², hemodialysis patients and healthy voluntary being assessed for a kidney donation or a nephrological check-up with no renal pathology..
10 secondary outcomes
Correlation between fasting plasma FGF19 concentration and Glomerular Filtration Rate (GFR)
Time frame: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and muscle strength
Time frame: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and muscle performance
Time frame: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and muscle quality
Time frame: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and muscle mass
Time frame: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and bone density
Time frame: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and bone quality in dialysis patients
Time frame: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and physical activity
Time frame: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and faecal bacterial microbiological profile
Time frame: At the end of the study (55 months)
Correlation between fasting plasma FGF19 concentration and the number of adverse events
Time frame: At the end of the study (55 months)
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 26 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal test and muscle biopsies in people with Chronic Kidney Diseases, run by Hospices Civils de Lyon at 1 site in France.
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 11 inclusion and 22 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 26 Mar 2025. 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 France. 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 Laetitia KOPPE, MD (+33 4 72 67 87 15, laetitia.koppe@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the fasting plasma concentration of FGF19 and the muscle mass (time frame: At the end of the study (55 months)). 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 26 Mar 2025.