Status:
RECRUITING
Impact of Dapagliflozin on Intestinal Microbiota Composition and on the Metabolites Derived from the Intestinal Microbiota in Non-diabetic Chronic Renal Failure Patients
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Chronic kidney disease (CKD) is a common disease affecting 10-12% of the adult population and characterize with high-risk cardiovascular morbidity and mortality with progression of CKD. Treatment with...
Eligibility Criteria
Inclusion
- Age between 18 and 80 years old
- Non-diabetic patient
- PChronic renal failure patient with a medical indication for the introduction of dapagliflozin as part of routine care: o either according to the marketing authorization, namely:
- A GFR estimated between 25 and 60 mL/min/1.73m2 according to the CKD EPI formula.
- A urinary albumin/creatinine ratio \> 200mg/g and \< 5000 mg/g
- Be treated with the maximum tolerated dose of renin-angiotensin system inhibitors for at least 4 weeks. o or according to the nephrologist's assessment if the patient has other indications such as chronic heart failure according to the marketing authorization or any patient with a GFR \> 20 ml/min according to the KDIGO recommendations for the management of CKD
- BMI between 18 and 30 kg/m2
- Patient not taking dapagliflozin (or any other treatment containing iSGLT2 or iSGLT1)
- Very regular bowel movements between 24 and 48 hours
- Patient following the dietary recommendations recommended during CKD (a sodium intake targeting 6g NaCl/day +/-20% and a protein intake of 0.6g/kg/d +/-20%)
- Affiliation to social security
Exclusion
- Taking drugs can interfere with the intestinal microbiota (prebiotics, probiotics, postbiotics, antibiotics) in the last 6 weeks
- Patient using high dose laxatives (more than 2 per day, for more than 3 months)
- Patient with a foreseeable transplant or dialysis project within the next 6 months.
- Patient with a colectomy, a resection of the small intestine or a cholecystectomy
- Patient with a progressive and unstabilized inflammatory, infectious, cardiovascular or neoplastic disease
- Inability to understand the nature, follow-up and possible consequences of the study.
- Patient in exclusion period from previous study or already participating in a clinical research protocol having an impact on the endpoints of the study
- Patient under guardianship or in safeguard of justice
- Pregnant, parturient or breastfeeding women
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05965440
Start Date
October 2 2023
End Date
August 20 2025
Last Update
December 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nephrology department, Hôpital Lyon Sud, Hospices Civils de Lyon
Lyon, France