Investigating FGF19's role in muscle health for chronic kidney disease patients
Role of FGF19 in Sarcopenia Associated with Chronic Kidney Disease
This study is testing if a growth factor called FGF19 can help improve muscle strength and mass in people with chronic kidney disease who are at risk of losing muscle.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Pierre-Bénite) |
| Trial ID | NCT04896047 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the effects of FGF19, a growth factor involved in metabolic regulation, on muscle mass and strength in patients with chronic kidney disease (CKD). It focuses on individuals with reduced kidney function or those undergoing dialysis, as they are at high risk for sarcopenia, which significantly impacts their quality of life. Participants will undergo meal tests and muscle biopsies to assess the relationship between FGF19 levels and muscle health. The study seeks to develop new pharmacological strategies to combat sarcopenia in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates include adults with chronic kidney disease characterized by an estimated GFR of less than 60 ml/min/1.73m² or those who have been on dialysis for more than three months.
Not a fit: Patients with a history of kidney transplant, certain gastrointestinal surgeries, or those with uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatments that improve muscle health and overall quality of life for patients with chronic kidney disease.
How similar studies have performed: While the specific approach of using FGF19 in this context is novel, previous studies have indicated the importance of addressing sarcopenia in CKD, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -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 Criteria: * 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
Where this trial is running
Pierre-Bénite
- Centre Hospitalier Lyon SUD — Pierre-Bénite, France (Recruiting)
Study contacts
- Study coordinator: Laetitia KOPPE, MD
- Email: laetitia.koppe@chu-lyon.fr
- Phone: +33 4 72 67 87 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.