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Impact of dapagliflozin for the regulation of immunological activity in Membranous Nephropathy
EU CTIS ID: 2023-507658-34-00
What this study is testing
Change in anti-PLA2R1 antibody titer (ELISA titer in RU/mL) from baseline to 6 months after dapagliflozin treatment compared with pretreatment antibody titer.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 immunological and clinical remission
- Antiproteinuric treatment at maximal and stable dose
You likely can't join if
- Immunosuppressive treatment for MN in the 6 months prior to the selection visit
- 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
- Secondary MN (associated with cancer, infectious disease, autoimmune or iatrogenic disease);
See the full eligibility 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 immunological and clinical remission
- Antiproteinuric treatment at maximal and stable dose
- Immunosuppressive treatment for MN in the 6 months prior to the selection visit
- 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
- 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.