Evaluating Dapagliflozin’s Effect on Immune Activity in Patients with Membranous Nephropathy

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What is this study about?

This clinical trial investigates the effects of dapagliflozin on Membranous Nephropathy, a kidney disease where the body’s immune system attacks the kidney’s filtering system. Membranous Nephropathy is associated with anti-PLA2R1 autoantibodies, which are proteins produced by the immune system that mistakenly target structures in the kidney. The purpose of the study is to evaluate how dapagliflozin affects these autoantibody levels in patients experiencing an immunological relapse of the disease.

The study will monitor patients over a 6-month period while they receive dapagliflozin treatment. During this time, researchers will track changes in antibody levels, protein in urine (proteinuria), albumin (a protein in blood), and kidney function as measured by glomerular filtration rate (how well the kidneys filter waste). The study will also analyze changes in various immune system signaling molecules called cytokines to better understand how the medication affects the immune response.

Participants will continue their existing antiproteinuric treatment (medication that reduces protein in urine) while adding dapagliflozin to their regimen. The safety and tolerance of dapagliflozin will be closely monitored throughout the study period to ensure participant wellbeing.

1 Initial Medication Phase

You will begin taking dapagliflozin (brand name Forxiga) as a 10 mg film-coated tablet. This medication will be taken once daily.

Dapagliflozin is being studied to see if it can help regulate immune activity in patients with Membranous Nephropathy (a kidney condition where the immune system attacks the filtering membranes in your kidneys).

Your current antiproteinuric treatment (medication that helps reduce protein in your urine) will continue at its maximum and stable dose alongside the study medication.

2 Baseline Measurements

At the beginning of the trial, your anti-PLA2R1 antibody levels will be measured. These are antibodies in your blood that are associated with Membranous Nephropathy.

Your urine will be tested to measure the Protein Creatinine Ratio (UPCR), which shows how much protein is leaking into your urine.

Blood tests will check your albumin levels (a protein in your blood) and your glomerular filtration rate (a measure of kidney function).

A cytokine profile will be taken, which measures levels of 9 different immune system signaling proteins in your body.

3 6-Month Treatment Period

You will continue taking the dapagliflozin 10 mg tablet daily for 6 months.

During this period, your medical team will monitor you for any side effects or tolerance issues related to the medication.

4 Final Measurements

After 6 months of treatment, all the tests from the baseline measurements will be repeated.

Your anti-PLA2R1 antibody levels will be measured again to compare with your starting levels (this is the main outcome being studied).

Your urine protein levels, blood albumin levels, and kidney function will be reassessed.

Your cytokine profile will be measured again to see if there have been changes in your immune system signaling.

5 Monitoring for Clinical Relapse

Throughout the study, you will be monitored for signs of clinical relapse of your condition.

If a relapse occurs, your medical team will assess if you need treatment with Rituximab (a medication that targets immune cells) according to kidney disease treatment guidelines.

Who Can Join the Study?

You must be between 18 and 84 years old
You must have membranous nephropathy (a type of kidney disease) with anti-PLA2R1 autoantibodies (specific antibodies in your blood that attack your kidneys)
Your urine protein-to-creatinine ratio (UPCR) must be between 0.5 and 3.5 g/g (this measures the amount of protein in your urine)
You must have had an immunological relapse, which means your anti-PLA2R1 antibody levels increased by more than 14 RU/mL after a period when both your symptoms and antibody levels were under control
You must be on a stable dose of medication to reduce protein in your urine

Who Cannot Join the Study?

Individuals younger than 18 years old cannot participate
Those who have a kidney condition not related to membranous nephropathy (a kidney disease where the kidney’s filtering units are damaged)
Pregnant women or women who are planning to become pregnant during the study
People who are breastfeeding
Those with type 1 diabetes (a condition where the body doesn’t produce insulin)
Individuals with urinary tract infections (infections in any part of the urinary system)
People with a history of genital infections (infections affecting the genital area)
Those who have severe liver problems
Individuals with known allergies to the study medication (dapagliflozin) or any of its components
People currently participating in another clinical trial
Those unable to provide informed consent
Individuals who have received another treatment for membranous nephropathy within the last 6 months

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Universitaire De Nice	Nice	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.05.2025

Trial locations

Investigated drugs:

Dapagliflozin

Dapagliflozin is a medication that belongs to a class of drugs called SGLT2 inhibitors. It works by helping the kidneys remove excess sugar from the blood through urine. In this trial, researchers are studying whether dapagliflozin can help regulate immune system activity in people with Membranous Nephropathy, a kidney disease caused by immune system problems. Specifically, they are looking at whether it can reduce antibodies that attack the kidneys.

Investigated diseases:

Glomerulonephritis membranous

Membranous Nephropathy – Membranous Nephropathy is a kidney disease characterized by thickening of the glomerular basement membrane due to immune deposits. It is an autoimmune condition where antibodies, often anti-PLA2R1, target proteins in the glomeruli, leading to protein leakage into the urine. The disease typically begins with protein in the urine (proteinuria) and can progress to cause low blood albumin levels and edema (swelling), collectively known as nephrotic syndrome. Over time, some patients may develop a gradual decline in kidney function. Membranous Nephropathy can follow a variable course, with some cases resolving spontaneously while others persist or progress more rapidly.

Trial ID:

2023-507658-34-00

Protocol code:

22-AOIP-06

Trial Phase:

Therapeutic use (Phase IV)

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Evaluating Dapagliflozin’s Effect on Immune Activity in Patients with Membranous Nephropathy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?