AuthorisedTherapeutic confirmatory (Phase III)Interventional

Early start corticosteroids versus standard care (RASBs followed by corticosteroids) for proteinuria in Immunoglobulin A Nephropathy (IgAN) patients with active renal lesions identified by kidney biopsy and RASBs combined with corticosteroids versus sodium-glucose cotransporter2 inhibitor combined with RASBs for proteinuria and renal function in IgAN patients with chronic renal lesions identified by kidney biopsy. A PROJECT FOR TWO MULTICENTRE, PROSPECTIVE OPEN LABEL RANDOMIZED CLINICAL STUDIES TO EVALUATE THE EFFECT OF TARGETED THERAPY BASED ON KIDNEY BIOPSY FINDINGS IN IgAN PATIENTS (CLIgAN)

This research is investigating treatments for a kidney condition called IgA nephropathy (IgAN). The study is split into two parts, based on what doctors see in a kidney biopsy. One part looks at starting steroids early compared to standard care for people with changes in their kidneys that are more active. The second part compares a combination of common blood pressure medicines and steroids with a newer drug called dapagliflozin (along with blood pressure medicines) for those with more long-term kidney damage. The main goal is to find out which treatments are best at reducing protein in the urine (a sign of kidney damage) and slowing down kidney disease progression over time. This is a large study involving many hospitals.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fondazione Schena Centro Europeo Della Ricerca Sulle Malattie Renali

Enrolment target

432

Start

16 Oct 2024

Idiopathic IgA nephropathy (IgAN)

What is this study about?

This important study is about a kidney condition called IgA nephropathy, or IgAN for short. In IgAN, your immune system mistakenly attacks your kidneys, leading to damage. A key sign of this damage is having too much protein in your urine, which doctors call proteinuria. Over time, this can lead to serious kidney problems and even kidney failure.

The study is actually two studies in one, designed to help doctors understand the best way to treat IgAN based on what they see when they look closely at a small sample of your kidney tissue (a kidney biopsy). One part of the study focuses on people whose kidney biopsy shows more active inflammation. It compares giving a type of medicine called corticosteroids (like prednisone) early on, against the usual care which typically starts with blood pressure medicines first, then adds corticosteroids if needed.

The second part of the study is for people whose kidney biopsy shows more long-term changes or scarring. This part compares the standard treatment of blood pressure medicines plus corticosteroids, with a newer medicine called dapagliflozin (which also helps with blood pressure) combined with blood pressure medicines. The main aim for both studies is to see how well these different treatments reduce protein in the urine, and importantly, how well they protect your kidney function over several years. This research is important because it could help doctors choose the most effective treatments for patients with IgAN in the future, tailored to their specific kidney problems.

Key takeaways

This study evaluates new ways to treat IgA nephropathy (IgAN).
It compares different medications based on specific kidney biopsy findings.
The main goals are to reduce protein in the urine and protect kidney function.
The study involves corticosteroids, dapagliflozin, and common blood pressure medicines.
It aims to find the best tailored treatment approaches for IgAN patients.

Who may be eligible?

This study is looking for adults aged 18 years and older. Both men and women can take part. To be considered, your doctors would need to have diagnosed you with IgA nephropathy after performing a kidney biopsy.

Having a kidney biopsy is a key requirement because the study groups are decided based on what your biopsy shows – whether your kidney damage is more active or more long-term. You would also need to meet other specific health criteria, which your doctor would check against the study guidelines.

If you have other serious health conditions or are taking certain medications, you might not be able to join. However, the best way to find out if this study is right for you is to talk to your kidney specialist.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with IgA nephropathy through a kidney biopsy?
Are you able to attend regular clinic appointments?
Are you comfortable potentially being assigned to different treatment groups?
Are you prepared for blood and urine tests throughout the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of the treatment groups, meaning you won't choose which drug you receive. This is standard in studies to ensure fair comparison. You'll regularly visit the clinic for check-ups, blood tests, and urine tests to monitor your kidney function and protein levels. You'll also be taking study medications as prescribed.

The study will follow your progress for up to three years. During this time, the medical team will carefully track how well the treatments are working and any side effects you might experience. They will also collect information like your blood pressure and general health at each visit.

Potential risks and benefits

Participating in a clinical trial offers the chance to receive close medical attention and access to new treatments before they are widely available, which might improve your kidney health. However, there are potential risks, as any medication can have side effects. For example, corticosteroids can have a range of side effects, and all medications carry some risk. You will be closely monitored for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Italy

Common questions

What is IgA nephropathy?

IgA nephropathy is a common kidney disease where a part of your immune system (called IgA) builds up in your kidneys, causing inflammation and damage, which can lead to kidney problems over time.

What is a kidney biopsy?

A kidney biopsy is a procedure where a very small piece of kidney tissue is taken. It helps doctors look closely at your kidney cells under a microscope to understand the type and extent of kidney damage.

What does 'protein in the urine' mean and why is it important?

Protein in the urine (proteinuria) means your kidneys are not filtering waste as well as they should, allowing protein to leak out. It's an important sign of kidney damage and doctors try to reduce it.

What are corticosteroids?

Corticosteroids are strong anti-inflammatory medicines, like prednisone, that reduce swelling and calm down the immune system. They are often used to treat kidney diseases.

What is dapagliflozin?

Dapagliflozin is a type of medicine that helps lower blood sugar in people with diabetes, but it has also been found to protect the kidneys in people with kidney disease, even if they don't have diabetes.