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Kidney drug may work through gut bacteria, study hints

NCT ID NCT05965440

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study looked at 50 non-diabetic people with chronic kidney disease to see if the drug dapagliflozin changes the types of bacteria in their gut. Researchers measured gut bacteria diversity and related waste products in the blood before and after 12 weeks of treatment. The goal was to understand how dapagliflozin might protect the kidneys beyond its known effects on blood sugar.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapagliflozin
What this could lead to
If successful, this could help explain how dapagliflozin protects the kidneys, potentially leading to better treatments for chronic kidney disease.
What could go wrong
This is a small, observational study with only 50 participants and no control group. It looks at biological changes, not direct health outcomes, so results may not lead to clear conclusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

Nov 2023

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Nephrology department, Hôpital Lyon Sud, Hospices Civils de Lyon

    Lyon, France

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