FGF19 and Chronic Kidney Disease

NCT04896047 | Recruiting

• 1 other identifier: 69HCL19_0823
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• 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..

  At the end of the study (55 months)

Secondary Outcomes (10)

• Correlation between fasting plasma FGF19 concentration and Glomerular Filtration Rate (GFR)

  At the end of the study (55 months)

• Correlation between fasting plasma FGF19 concentration and muscle strength

  At the end of the study (55 months)

• Correlation between fasting plasma FGF19 concentration and muscle performance

  At the end of the study (55 months)

• Correlation between fasting plasma FGF19 concentration and muscle quality

  At the end of the study (55 months)

• Correlation between fasting plasma FGF19 concentration and muscle mass

  At the end of the study (55 months)

Study Arms (3)

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.

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

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

Procedure: Meal test and muscle biopsies

Interventions

Meal test and muscle biopsies PROCEDURE

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.

CKD patients; Haemodialysis patients; Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre Hospitalier Lyon SUD

Pierre-Bénite, 69310, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

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

Central Study Contacts

Laetitia KOPPE, MD

CONTACT

+33 4 72 67 87 15; laetitia.koppe@chu-lyon.fr

Cécile BARNEL

CONTACT

+33 4 78 86 37 12; cecile.barnel@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: May 21, 2021
• Study Start: July 6, 2022
• Primary Completion (Estimated): February 6, 2027
• Study Completion (Estimated): February 6, 2027
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

FR (1)