GlomerulonephritisPhase 2FORXIGEMNCT07096986
Impact of Dapagliflozin for the Regulation of Immunological Activity in Membranous Nephropathy
A Phase 2 study testing Forxiga in people with Glomerulonephritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
WHY IS THIS RESEARCH BEING CONDUCTED? Membranous glomerulonephritis (MN) is an autoimmune disease that affects the kidneys through autoantibodies, meaning that antibodies produced by your body attack your own kidney cells. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Glomerulonephritis
- What is being tested?
- Forxiga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2026to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de NICE
Nice
Céline FERNANDEZ, +33492038828, fernandez.c3@chu-nice.fr
Maxime TEISSEYRE, MD
About this study
Official title: Impact of Dapagliflozin for the Regulation of Immunological Activity in Membranous
WHY IS THIS RESEARCH BEING CONDUCTED? Membranous glomerulonephritis (MN) is an autoimmune disease that affects the kidneys through autoantibodies, meaning that antibodies produced by your body attack your own kidney cells. The appearance of these autoantibodies can be explained in part by a disruption in the immune response. Patients with this disease are treated with immunosuppressive drugs such as rituximab. The aim of this treatment is to reduce the production of all antibodies, including those responsible for the disease. Despite this treatment, some patients may experience a relapse of the disease. These relapses can be complicated by infections, blood clots in the blood vessels, and, in the long term, can lead to kidney failure and an increased cardiovascular risk. Relapses can also have an impact on patients' social and professional lives.
Dapagliflozin is a diuretic medication, which means that it is used to increase urine production and eliminate excess salt and water from the body to reduce edema (swelling). It is currently prescribed and authorized for patients with type 2 diabetes, heart failure and chronic kidney disease. This treatment has been shown to reduce the amount of proteins in the urine and protect the kidneys and cardiovascular system in patients with chronic kidney disease. A study has also shown that dapagliflozin may have an effect on the immune response.
Read more
WHAT DOES IT INVOLVE? The aim of our study will be to evaluate the efficacy of dapagliflozin in reducing disease autoantibodies and preventing relapses.
This research will be conducted at the Nice University Hospital and the Nîmes University Hospital. We expect to 20 patients to be recruited with an anti-PLA2R1 positive MN.
Participation in the study will last 6 months. The research is funded by Nice University Hospital. WHAT IS THE TREATMENT BEING STUDIED? It is dapagliflozin, a drug that is increasingly used routinely in patients with nephrotic syndrome (including MN) for its ability to reduce protein in the urine. Its effect on the immune system in MN has not yet been studied
- Conditions
- Glomerulonephritis
- Being tested
- Forxiga
- Medical subject headings
- Glomerulonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForxigaDrug
dapagliflozin treatment at a dose of 10 mg per os daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| FORXIGA | Experimental | Not described Receives: Drug: Forxiga |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure immunological activity (anti-PLA2R1 antibody concentration) in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse, before and after 6 months of dapagliflozin treatment.
Change in anti-PLA2R1 antibody titer (ELISA titer in RU/mL) from baseline to 6 months after dapagliflozin treatment compared with pretreatment antibody titer.
Measured: 6 months
Secondary outcomes (7)
To measure the change in proteinuria over the course of the study in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse
Change in proteinuria (in g/g) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment)
Measured: 6 months
To measure the change in serum albumin levels over the course of the study in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse
Change in albumin levels (in g/L) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment)
Measured: 6 months
To measure the change in glomerular filtration rate over the course of the study in anti- PLA2R1 antibodies positive MN patients undergoing an immunological relapse
Change in glomerular filtration rate (in ml/min/1.73m2) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment)
Measured: 6 months
To measure the occurrence of clinical relapses over the course of the study in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse
Need for Rituximab treatment for clinical relapse (according to KDIGO 2021 guidelines and French 2022 guidelines)
Measured: 6 months
To measure the production of Th17, Th2 and Treg pathway cytokines in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse, before and after 6 months of dapagliflozin treatment
Change in cytokine profile from baseline to 6 months after dapagliflozin treatment
Measured: 6 months
To assess the dapagliflozin treatment's safety in MN patients
Appearance of side effects
Measured: 6 months
To assess the dapagliflozin treatment's safety in MN patients
Appearance of biological disorder
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Nov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlomerulonephritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096986
- Sponsor's protocol ID
- 22-AOIP-06
- Acronym
- FORXIGEM
- Status last verified
- Jun 2026
- First submitted
- 7 Jul 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not scheduled
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dapagliflozin for the Regulation of Immunological Activity in Membranous
- ClinicalTrials.gov ID
- NCT07096986
- Acronym / sponsor ID
- FORXIGEM / 22-AOIP-06
- Conditions
- Glomerulonephritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 31 Jul 2025 (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.
WHY IS THIS RESEARCH BEING CONDUCTED? Membranous glomerulonephritis (MN) is an autoimmune disease that affects the kidneys through autoantibodies, meaning that antibodies produced by your body attack your own kidney cells. The appearance of these autoantibodies can be explained in part by a disruption in the immune response. Patients with this disease are treated with immunosuppressive drugs such as rituximab. The aim of this treatment is to reduce the production of all antibodies, including those responsible for the disease. Despite this treatment, some patients may experience a relapse of the disease. These relapses can be complicated by infections, blood clots in the blood vessels, and, in the long term, can lead to kidney failure and an increased cardiovascular risk. Relapses can also have an impact on patients' social and professional lives.
Dapagliflozin is a diuretic medication, which means that it is used to increase urine production and eliminate excess salt and water from the body to reduce edema (swelling). It is currently prescribed and authorized for patients with type 2 diabetes, heart failure and chronic kidney disease. This treatment has been shown to reduce the amount of proteins in the urine and protect the kidneys and cardiovascular system in patients with chronic kidney disease. A study has also shown that dapagliflozin may have an effect on the immune response.
WHAT DOES IT INVOLVE? The aim of our study will be to evaluate the efficacy of dapagliflozin in reducing disease autoantibodies and preventing relapses.
This research will be conducted at the Nice University Hospital and the Nîmes University Hospital. We expect to 20 patients to be recruited with an anti-PLA2R1 positive MN.
Participation in the study will last 6 months. The research is funded by Nice University Hospital. WHAT IS THE TREATMENT BEING STUDIED? It is dapagliflozin, a drug that is increasingly used routinely in patients with nephrotic syndrome (including MN) for its ability to reduce protein in the urine. Its effect on the immune system in MN has not yet been studied
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FORXIGA | Experimental | Drug: Forxiga |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%).
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Forxigadapagliflozin treatment at a dose of 10 mg per os daily for 6 months | Drug | FORXIGA |
Primary outcome
To measure immunological activity (anti-PLA2R1 antibody concentration) in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse, before and after 6 months of dapagliflozin treatment.
Time frame: 6 months
Change in anti-PLA2R1 antibody titer (ELISA titer in RU/mL) from baseline to 6 months after dapagliflozin treatment compared with pretreatment antibody titer.
7 secondary outcomes
To measure the change in proteinuria over the course of the study in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse
Time frame: 6 months
To measure the change in serum albumin levels over the course of the study in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse
Time frame: 6 months
To measure the change in glomerular filtration rate over the course of the study in anti- PLA2R1 antibodies positive MN patients undergoing an immunological relapse
Time frame: 6 months
To measure the occurrence of clinical relapses over the course of the study in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse
Time frame: 6 months
To measure the production of Th17, Th2 and Treg pathway cytokines in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse, before and after 6 months of dapagliflozin treatment
Time frame: 6 months
To assess the dapagliflozin treatment's safety in MN patients
Time frame: 6 months
To assess the dapagliflozin treatment's safety in MN patients
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No. not scheduled
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Forxiga in people with Glomerulonephritis, run by Centre Hospitalier Universitaire de Nice 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 5 inclusion and 14 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: opening soon, as of the sponsor's last update on 22 Jun 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime TEISSEYRE (0492035171, teisseyre.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure immunological activity (anti-PLA2R1 antibody concentration) in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse, before and after 6 months of dapagliflozin treatment. (time frame: 6 months). 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 22 Jun 2026.