Impact of Dapagliflozin on Intestinal Microbiota Composition and on the Metabolites Derived From the Intestinal Microbiota in Non-diabetic Chronic Renal Failure Patients (DAPA-GUT)
Chronic Kidney Diseases
About this trial
This is an interventional diagnostic trial for Chronic Kidney Diseases focused on measuring CKD, gliflozine, gut microbiota, metabolomic, uremic toxin
Eligibility Criteria
Inclusion Criteria: Age between 18 and 80 years old Non-diabetic patient Patient with a medical indication for the introduction of dapagliflozin according to the Marketing Authorization and as part of routine care, ie: An estimated GFR 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. 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 Criteria: 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
Sites / Locations
- Nephrology department, Hôpital Lyon Sud, Hospices Civils de LyonRecruiting
Arms of the Study
Arm 1
Other
impact of Dapagliflozin on Intestinal Microbiota on chronic renal failure patients
Addition of 3 blood tubes of 5mL during the collection for the treatment Collection of fresh urine (7 mL) Collection of stools by the participant at his home Collection of fresh stools for patients participating in the ancillary study Constitution of a biocollection (blood, urine and stool) Food collection for 3 days with no impact on patient follow-up Stool appearance sheet to be completed by the patient at each collection