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Could a diabetes drug tame the immune system in kidney disease?

NCT ID NCT07096986

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tests whether dapagliflozin, a drug used for diabetes and heart failure, can reduce harmful antibodies and prevent relapses in people with membranous nephropathy, an autoimmune kidney disease. The study enrolls 20 adults who have had a recent rise in anti-PLA2R1 antibodies after a period of remission. Participants take dapagliflozin daily for 6 months, and researchers measure changes in antibody levels and protein in the urine.

What this could mean

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

Active substance
dapagliflozin (Forxiga)
What this could lead to
If it works, dapagliflozin could offer a new way to control autoimmune kidney disease and reduce relapses without heavy immunosuppression.
What could go wrong
This is a small, early-phase trial with only 20 participants. The drug's immune effects in this disease are unproven, and it may not reduce antibodies or prevent relapses as hoped.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

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 84 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Participants ≥ 18 years old and \< 85 years old; * Membranous Nephropathy associated with anti-PLA2R1 autoantibodies; * Urine Protein Creatinine Ratio (UPCR) between 0.5 g/g and 3.5 g/g; * Immunological relapse defined by an increase in anti-PLA2R1 antibody concentration \> 14 RU/mL after a phase of anti-PLA2R1 antibody negativation, (i.e. immunological remission) and complete or partial clinical remission; * Antiproteinuric treatment at maximal and stable dose. According to KDIGO 2024 guidelines on management of glomerular diseases and the French recommendations (PNDS GEM 2022), symptomatic treatment of membranous nephropathy should include: (i) a low sodium diet, (ii) a diuretic and (iii) an angiotensin-converting enzyme inhibitor or an angiotensin 2 receptor blocker at maximal tolerated dose (i.e., absence of orthostatic hypotension and no increase in serum creatinine \>30%). Exclusion Criteria: * Immunosuppressive treatment for MN in the 6 months prior to the selection visit; * Secondary MN (associated with cancer, infectious disease, autoimmune or iatrogenic disease); * Active nephrotic syndrome defined according to KDIGO guidelines as proteinuria \> 3.5 g/day (or 3.5 g/g in a urine sample) and albumin \< 30 g/L; * No previous history of immunological remission (anti-PLA2R1 antibodies \< 14 RU/mL in ELISA or negative indirect immunofluorescence) or clinical remission (partial or complete); * Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption disorders * Patients at risk for ketoacidosis including patients with a low reserve of functional beta cells (e.g. patients with type 2 diabetes with low C-peptide or latent autoimmune diabetes mellitus or patients with a history of pancreatitis or patients who are receiving insulin treatment), patients with conditions leading to reduced food intake or severe dehydration, patients with low insulin reserve, and patients with increased insulin requirements due to acute medical illness, surgery or excessive alcohol consumption; * Type 1 diabetes; * Pregnancy or breastfeeding; * Estimated CKD-EPI Glomerular Filtration Rate (eGFR) \< 25 ml/min/1.73m2; * Severe liver failure (Child-Pugh stage C); * NYHA functional class IV heart failure; * Patients already currently receiving dapagliflozin or another SGLT2 inhibitor for another condition; * Repeated urinary tract infections; * Hypersensitivity to the active substance or excipients.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de NICE

    Nice, France

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Other studies related to the condition(s) this trial covers.