Chronic Kidney DiseasesDAPA-GUTNCT05965440
Impact of Dapagliflozin on Intestinal Microbiota Composition and on the Metabolites Derived From the Intestinal Microbiota in Non-diabetic Chronic Renal Failure Patients
A study testing impact of Dapagliflozin on Intestinal Microbiota on chronic renal failure patients in people with Chronic Kidney Diseases, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- impact of Dapagliflozin on Intestinal Microbiota on chronic renal failure patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2023to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Nephrology department, Hôpital Lyon Sud, Hospices Civils de Lyon
Lyon
About this study
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 sodium-glucose cotransporter 2 inhibitors (iSGLT2) not only improves hyperglycemia and type 2 diabetes (T2D) but also results in body-weight loss, a reduction in blood pressure, and a decrease of cardiovascular events and progression of renal failure in both diabetes and non-diabetes patients.(Heerspink et al. 2020) Therefore, dapagliflozin is now associated with the inhibitors of the renin-angiotensin system to reduce kidney events.
However, the mechanisms underlying the effects of dapagliflozin on the renal function remain unclear. When renal failure occurs, it impairs the removal of several metabolites called uremic retention solutes. If these retention solutes exhibit deleterious interferences with biochemical/physiological functions, they are referred to as uremic toxins as they can contribute to the manifestations of the uremic syndrome and are associated with a high cardiovascular morbidity and mortality and with progression of CKD. Many of the uremic toxins are not produced by the body itself but rather derived from gut microbiota metabolism such as the well-known trimethylamine-N-oxide (TMAO),p-cresyl sulfate (PCS), phenyl sulfate (PS), indoxyl sulfate (IS), and indole-3-acetic acid (IAA).The gut microbiota composition in a uremic context has been the subject of an increasing number of publications and majority of them confirm a decrease of gut microbiota richness and deep modifications.Recently, an animal study suggested that dapagliflozin, subtly improve the composition of the gut microbiota in mice with T2D and another preliminary clinical study didn't observe a modification in the fecal microbiome after dapagliflozin initiation.But in other study, empagliflozin significantly reshaped the gut microbiota after 1 month of treatment in T2D patients and be associated with shifts in plasma metabolites. Similarly, canagliflozin reduces plasma uremic toxins in a CKD mice model.However, it remains unknown whether treatment with dapagliflozin alters the gut microbiota in CKD patients without T2D; furthermore, the relationship between the gut microbiota, uremic toxins production and CKD-related beneficial effects of dapagliflozin remains elusive.
Herein, the investigator will investigate the clinical benefits of dapagliflozin and possible associations between its renal function benefits and alterations in plasmatic gut microbiota-derived metabolites and the gut microbiota composition in non-T2D CKD patients. To this end, the investigator will conduct an observational clinical trial in non-T2D CKD patients with the primary aim of investigating dapagliflozin-induced compositional changes of intestinal gut microbiota.
- Conditions
- Chronic Kidney Diseases
- Being tested
- impact of Dapagliflozin on Intestinal Microbiota on chronic renal failure patients
- Keywords
- CKD, gliflozine, gut microbiota, metabolomic, uremic toxin
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impact of Dapagliflozin on Intestinal Microbiota on chronic renal failure patientsDrug
Analysis of microbiota
| Study group | Role | What they receive |
|---|---|---|
| impact of Dapagliflozin on Intestinal Microbiota on chronic renal failure patients | Other | * 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 Receives: Drug: impact of Dapagliflozin on Intestinal Microbiota on chronic renal failure patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha diversity and beta diversity size of the intestinal microbiota after 12 weeks of daily treatment with dapagliflozin compared to alfa and beta diversity size before initiation of treatment.
The analysis of the microbiota by 16s sequencing of bacterial DNA will be carried out on the GenEPII platform located at the Croix Rousse hospital, Hospices Civils de Lyon (Pr Sophie JARRAUD).
Measured: Before and 12 weeks after initiation of treatment with dapagliflozin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start20 Nov 2023
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965440
- Sponsor's protocol ID
- 69HCL23_0410
- Acronym
- DAPA-GUT
- Status last verified
- Feb 2026
- First submitted
- 20 Jul 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dapagliflozin on Intestinal Microbiota Composition and on the Metabolites Derived From the Intestinal Microbiota in Non-diabetic Chronic Renal Failure Patients
- ClinicalTrials.gov ID
- NCT05965440
- Acronym / sponsor ID
- DAPA-GUT / 69HCL23_0410
- Conditions
- Chronic Kidney Diseases
- Keywords
- CKD, gliflozine, gut microbiota, metabolomic, uremic toxin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 sodium-glucose cotransporter 2 inhibitors (iSGLT2) not only improves hyperglycemia and type 2 diabetes (T2D) but also results in body-weight loss, a reduction in blood pressure, and a decrease of cardiovascular events and progression of renal failure in both diabetes and non-diabetes patients.(Heerspink et al. 2020) Therefore, dapagliflozin is now associated with the inhibitors of the renin-angiotensin system to reduce kidney events.
However, the mechanisms underlying the effects of dapagliflozin on the renal function remain unclear. When renal failure occurs, it impairs the removal of several metabolites called uremic retention solutes. If these retention solutes exhibit deleterious interferences with biochemical/physiological functions, they are referred to as uremic toxins as they can contribute to the manifestations of the uremic syndrome and are associated with a high cardiovascular morbidity and mortality and with progression of CKD. Many of the uremic toxins are not produced by the body itself but rather derived from gut microbiota metabolism such as the well-known trimethylamine-N-oxide (TMAO),p-cresyl sulfate (PCS), phenyl sulfate (PS), indoxyl sulfate (IS), and indole-3-acetic acid (IAA).The gut microbiota composition in a uremic context has been the subject of an increasing number of publications and majority of them confirm a decrease of gut microbiota richness and deep modifications.Recently, an animal study suggested that dapagliflozin, subtly improve the composition of the gut microbiota in mice with T2D and another preliminary clinical study didn't observe a modification in the fecal microbiome after dapagliflozin initiation.But in other study, empagliflozin significantly reshaped the gut microbiota after 1 month of treatment in T2D patients and be associated with shifts in plasma metabolites. Similarly, canagliflozin reduces plasma uremic toxins in a CKD mice model.However, it remains unknown whether treatment with dapagliflozin alters the gut microbiota in CKD patients without T2D; furthermore, the relationship between the gut microbiota, uremic toxins production and CKD-related beneficial effects of dapagliflozin remains elusive.
Herein, the investigator will investigate the clinical benefits of dapagliflozin and possible associations between its renal function benefits and alterations in plasmatic gut microbiota-derived metabolites and the gut microbiota composition in non-T2D CKD patients. To this end, the investigator will conduct an observational clinical trial in non-T2D CKD patients with the primary aim of investigating dapagliflozin-induced compositional changes of intestinal gut microbiota.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| impact of Dapagliflozin on Intestinal Microbiota on chronic renal failure patients | Other | Drug: 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- BMI between 18 and 30 kg/m2
- Patient not taking dapagliflozin (or any other treatment containing iSGLT2 or iSGLT1)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| impact of Dapagliflozin on Intestinal Microbiota on chronic renal failure patientsAnalysis of microbiota | Drug | impact of Dapagliflozin on Intestinal Microbiota on chronic renal failure patients |
Primary outcome
Alpha diversity and beta diversity size of the intestinal microbiota after 12 weeks of daily treatment with dapagliflozin compared to alfa and beta diversity size before initiation of treatment.
Time frame: Before and 12 weeks after initiation of treatment with dapagliflozin
The analysis of the microbiota by 16s sequencing of bacterial DNA will be carried out on the GenEPII platform located at the Croix Rousse hospital, Hospices Civils de Lyon (Pr Sophie JARRAUD).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing impact of Dapagliflozin on Intestinal Microbiota on chronic renal failure patients in people with Chronic Kidney Diseases, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha diversity and beta diversity size of the intestinal microbiota after 12 weeks of daily treatment with dapagliflozin compared to alfa and beta diversity size before initiation of treatment. (time frame: Before and 12 weeks after initiation of treatment with dapagliflozin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.