Impact of dapagliflozin for the regulation of immunological activity in Membranous Nephropathy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nice

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

19 Sep 2025 → ongoing

Decision date (initial)

2025-07-15

Transition trial

No

Low-intervention

Yes

Rare-disease indication

Yes

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

Change in anti-PLA2R1 antibody titer (ELISA titer in RU/mL) from baseline to 6 months after dapagliflozin treatment compared with pretreatment antibody titer.

Secondary objectives 6

1. 1- To measure the change in proteinuria over the course of the study in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse
2. 2- 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
3. 3- 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
4. 4- To measure the occurrence of clinical relapses over the course of the study in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse
5. 5- To measure the production of Th17, Th1, Th2 and Treg pathway cytokines in anti-PLA2R1 antibodies positive MN patients undergoing an immunological relapse, before and after 6 months of dapagliflozin treatment;
6. To assess the dapagliflozin treatment’s safety in MN patient

Conditions and MedDRA coding

Membranous Nephropathy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participants ≥ 18 years old and < 85 years old
2. Membranous Nephropathy associated with anti-PLA2R1 autoantibodies
3. Urine Protein Creatinine Ratio (UPCR) between 0.5 g/g and 3.5 g/g
4. Immunological relapse defined by an increase in anti-PLA2R1 antibody concentration > 14 RU/mL after a phase of immunological and clinical remission
5. Antiproteinuric treatment at maximal and stable dose

Exclusion criteria 13

1. Immunosuppressive treatment for MN in the 6 months prior to the selection visit
2. Secondary MN (associated with cancer, infectious disease, autoimmune or iatrogenic disease);
3. 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
4. No previous history of immunological remission (anti-PLA2R1 antibodies < 14 RU/mL in ELISA or negative indirect immunofluorescence) or clinical remission (partial or complete)
5. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption disorders
6. Type 1 diabetes
7. Pregnancy or breastfeeding
8. Estimated CKD-EPI Glomerular Filtration Rate (eGFR) < 25 ml/min/1.73m2
9. Severe liver failure (Child-Pugh stage C)
10. NYHA functional class IV heart failure
11. Patients already currently receiving dapagliflozin or another SGLT2 inhibitor for another condition
12. Repeated urinary tract infections
13. Hypersensitivity to the active substance or excipients

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in anti-PLA2R1 antibody titer (ELISA titer in RU/mL) from baseline to 6 months after dapagliflozin treatment compared with pretreatment antibody titer

Secondary endpoints 6

1. Change in proteinuria (in g/g) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment)
2. Change in albumin levels (in g/L) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment)
3. Change in glomerular filtration rate (in ml/min/1.73m2) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment)
4. Need for Rituximab treatment for clinical relapse (according to KDIGO 2021 guidelines and French 2022 guidelines)
5. Change in cytokine profile from baseline to 6 months after dapagliflozin treatment (analysis of 9 cytokines: IL-12p70; IL-17A; IL-4; IL-5; IL-1β; IL-10; IFNα; IL-6 and IFNγ)
6. Clinical and biological tolerance of dapagliflozin treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nice

Sponsor organisation

Centre Hospitalier Universitaire De Nice

Address

4 Avenue Reine Victoria

City

Nice

Postcode

06000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Céline Fernandez

Public contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Céline Fernandez

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications