Effects of Dapagliflozin on Gut Bacteria in Non-Diabetic Kidney Disease Patients
Impact of Dapagliflozin on Intestinal Microbiota Composition and on the Metabolites Derived from the Intestinal Microbiota in Non-diabetic Chronic Renal Failure Patients
This study is testing if the medication dapagliflozin can change gut bacteria and help improve kidney function in non-diabetic patients with chronic kidney disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05965440 on ClinicalTrials.gov |
What this trial studies
This study investigates how dapagliflozin, a medication typically used for diabetes, affects the composition of intestinal microbiota and the metabolites produced by these bacteria in patients with chronic kidney disease (CKD) who are not diabetic. The research aims to understand the mechanisms by which dapagliflozin may improve kidney function and reduce harmful uremic toxins in these patients. Eligible participants will be non-diabetic adults with chronic renal failure who meet specific criteria for dapagliflozin treatment. The study will monitor changes in gut bacteria and related metabolites over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates are non-diabetic adults aged 18 to 80 with chronic renal failure and specific indications for dapagliflozin treatment.
Not a fit: Patients who are diabetic or those with severe renal impairment not meeting the study criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of chronic kidney disease and better health outcomes for patients through the modulation of gut microbiota.
How similar studies have performed: While the effects of dapagliflozin on kidney function have been studied, the specific impact on gut microbiota in non-diabetic patients with CKD is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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
Where this trial is running
Lyon
- Nephrology department, Hôpital Lyon Sud, Hospices Civils de Lyon — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Laetitia KOPPE, M.D., Ph. D
- 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.