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Study on Corticosteroids, Dapagliflozin, and Drug Combination for Proteinuria in IgA Nephropathy Patients with Active or Chronic Kidney Lesions

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a kidney disease called Immunoglobulin A Nephropathy (IgAN), which affects the kidneys' ability to filter waste from the blood. The study aims to evaluate different treatment approaches for patients with this condition. One part of the study will look at the effects of starting treatment with corticosteroids early, compared to the standard care of using medications called Renin-Angiotensin System Blockers (RASBs) followed by corticosteroids. Another part of the study will compare the combination of a medication called Dapagliflozin with RASBs against corticosteroids combined with RASBs for patients with more chronic kidney issues.

Participants in the study will receive one of the treatments being tested, which may include medications like Ramipril, Losartan, Methylprednisolone, Prednisone, or Dapagliflozin. Some participants may receive a placebo. The study will observe the effects of these treatments on the amount of protein in the urine, which is a sign of kidney damage, and on kidney function over time. The study will last for several months, with regular check-ups to monitor the participants' health and the effectiveness of the treatments.

The purpose of this study is to find out which treatment approach is more effective in reducing protein levels in the urine and improving kidney function in patients with IgAN. By comparing these different treatments, researchers hope to provide better care options for people living with this kidney disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be assigned to one of two groups based on their kidney biopsy results. This assignment is random and helps ensure the study's reliability.
Step 2
Treatment for active renal lesions
Participants with active renal lesions will receive early treatment with corticosteroids after their kidney biopsy. This involves taking prednisone orally. The dosage and frequency will be determined by the study team based on individual needs.
The goal is to evaluate the effect of early corticosteroid therapy on reducing protein levels in the urine.
Step 3
Standard care for active renal lesions
Participants in the standard care group will initially receive RASBs (renin-angiotensin system blockers), which may include medications like ramipril or losartan. These are taken orally as per clinical practice.
After a period, corticosteroids will be added to the treatment to assess their combined effect on protein levels in the urine.
Step 4
Treatment for chronic or moderate renal lesions
Participants with chronic or moderate renal lesions will receive a combination of SGLT2i (sodium-glucose cotransporter 2 inhibitor) and RASBs. The SGLT2i used in this study is dapagliflozin, taken orally.
The aim is to compare the effect of this combination on protein levels in the urine with the effect of corticosteroids combined with RASBs.
Step 5
Monitoring and follow-up
Throughout the study, participants will have regular check-ups to monitor their kidney function and protein levels in the urine. This includes blood tests and urine tests.
The primary goal is to observe changes in protein levels over time, with specific assessments at 4, 8, and 10 months, depending on the group assignment.
Step 6
Long-term evaluation
Participants will be followed for up to three years to assess the long-term effects of the treatments on kidney function. This includes measuring the rate of decline in kidney function and any significant changes in protein levels.
The study aims to determine the most effective treatment strategy for managing protein levels and preserving kidney function in patients with IgA nephropathy.

Who can join the trial?

6 criteria

Men and women aged 18 to 75 years can participate.
You must provide a signed consent form to show you understand the study and agree to participate.
You need to have a kidney biopsy that shows you have idiopathic IgA nephropathy (IgAN). This means a kidney test confirms the condition.
Your kidney function, measured by a test called eGFR, should be at least 30 ml/min/1.73 m². This test checks how well your kidneys are working.
Your urine protein level, measured over 24 hours, should be at least 0.5 grams. This checks for protein in your urine, which can indicate kidney issues.
You should be currently receiving or be a candidate for treatment with RASBs (either an ACEi or ARB). These are medications used to treat kidney conditions, as recommended by current guidelines.

Who cannot join the trial?

10 criteria

Patients with any other kidney disease besides Idiopathic IgA nephropathy (IgAN) cannot participate.
Patients who have had a kidney transplant are not eligible.
Patients with severe kidney damage that cannot be reversed are excluded.
Patients who are currently taking part in another clinical trial cannot join this study.
Patients with a history of severe allergic reactions to the study medications are not allowed.
Pregnant or breastfeeding women cannot participate in the trial.
Patients with uncontrolled high blood pressure are excluded.
Patients with severe liver disease cannot take part in the study.
Patients with a history of drug or alcohol abuse in the past year are not eligible.
Patients with any condition that the study doctors believe would make it unsafe for them to participate are excluded.

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Verified sites

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Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Di Sassari
Sassari, Italy
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Azienda Ospedaliero Universitaria Parma
Parma, Italy

Trial locations

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Investigated drugs

Corticosteroids
are a type of medication that helps reduce inflammation in the body. In this clinical trial, they are used to treat patients with Immunoglobulin A Nephropathy (IgAN), a kidney disease. The goal is to see if starting corticosteroid treatment early, right after a kidney biopsy, can help reduce protein levels in the urine for patients with active kidney problems.
RASBs
, or Renin-Angiotensin System Blockers, are medications that help control blood pressure and protect the kidneys. In this trial, they are used as part of the standard care for IgAN patients. The study aims to compare the effects of using RASBs alone followed by corticosteroids, against starting corticosteroids early, to see which approach is more effective in reducing protein in the urine.
Dapagliflozin
is a medication that belongs to a group called SGLT2 inhibitors. It helps lower blood sugar levels and can also have protective effects on the kidneys. In this trial, Dapagliflozin is combined with RASBs to see if this combination can reduce protein in the urine and improve kidney function in patients with chronic kidney problems, compared to using corticosteroids with RASBs. The aim is to find a treatment that avoids the potential side effects of corticosteroids.

What is already known about the treatment

Corticosteroids
Corticosteroids are typically administered orally or intravenously, depending on the specific needs of the patient. They are currently well-established in medical practice and literature for their anti-inflammatory and immunosuppressive properties. In the context of this clinical trial, they are used to treat proteinuria in patients with Idiopathic IgA Nephropathy (IgAN) who have active renal lesions. At the molecular level, corticosteroids work by reducing inflammation and suppressing the immune system's activity, which helps to decrease protein leakage in the kidneys. They belong to the pharmacological class of glucocorticoids.
Dapagliflozin
Dapagliflozin is administered orally in tablet form. It is a relatively newer medication in the medical field, primarily used for managing blood sugar levels in type 2 diabetes and is being explored for its benefits in kidney health. In this trial, it is used in combination with RASBs to treat proteinuria in patients with chronic renal lesions due to Idiopathic IgA Nephropathy (IgAN). Dapagliflozin works by inhibiting the sodium-glucose cotransporter 2 (SGLT2) in the kidneys, which helps to reduce glucose reabsorption and may have protective effects on kidney function. It is classified as an SGLT2 inhibitor.

Investigated diseases

Idiopathic IgA nephropathy (IgAN) – Idiopathic IgA nephropathy is a kidney disease characterized by the buildup of the antibody immunoglobulin A (IgA) in the kidneys. This accumulation leads to inflammation that can affect the kidneys' ability to filter waste from the blood. The disease often progresses slowly over many years. In its early stages, it may not cause noticeable symptoms, but as it advances, it can lead to blood or protein in the urine, swelling in the hands and feet, and high blood pressure. Over time, the persistent inflammation can result in chronic kidney damage. The progression of the disease varies among individuals, with some experiencing stable kidney function for years, while others may develop more severe kidney impairment.