Status:
RECRUITING
FGF19 and Chronic Kidney Disease
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Exclusion
- 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:
- 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
Key Trial Info
Start Date :
July 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 6 2027
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04896047
Start Date
July 6 2022
End Date
February 6 2027
Last Update
March 26 2025
Active Locations (1)
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1
Centre Hospitalier Lyon SUD
Pierre-Bénite, France, 69310