RecruitingOBSERVATIONAL

Non-invasive Diagnosis of Idiopathic Nephrotic Syndromes

This study aims to find a new, less invasive way to diagnose a kidney problem called Idiopathic Nephrotic Syndrome (INS). At the moment, doctors usually need to take a small sample from your kidney (a biopsy) to confirm this diagnosis. This procedure can be uncomfortable and sometimes risky, especially if you're already very unwell. Researchers have developed a new diagnostic score, called SNIT, which uses information from routine blood tests and your medical history. They believe this score might be able to tell if you have INS without the need for a biopsy, particularly if other specific blood tests for different kidney conditions are negative. This study will check if the SNIT score is accurate and reliable, potentially making diagnosis safer and easier for patients.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

265

Start

15 Apr 2025

Estimated completion

01 Aug 2027

Idiopathic Nephrotic Syndrome (INS)

What is this study about?

When doctors suspect you might have Idiopathic Nephrotic Syndrome (INS), a kidney condition, the usual way to confirm this is by performing a kidney biopsy. This involves taking a tiny piece of your kidney with a needle to look at it under a microscope. While effective, a biopsy is a medical procedure that carries some risks, like bleeding or infection, and can be particularly tricky when you're feeling very poorly.

Researchers are looking for a gentler way to find out if you have INS. They've developed something called the SNIT score. This score uses information that doctors already collect from routine blood tests, like how well your kidneys are working, and other details from your medical history. The idea is that if certain specific blood tests for other kidney conditions come back negative, the SNIT score could then help diagnose INS without needing that biopsy.

This study is all about testing how well this new SNIT score works. They want to see if it's as accurate as a kidney biopsy in diagnosing INS. If it proves to be reliable, it could mean fewer patients would need to go through the biopsy procedure, making the diagnosis process safer and more comfortable for people with suspected INS.

Key takeaways

This study evaluates a new, less invasive way to diagnose a kidney condition called INS.
It aims to reduce the need for kidney biopsies, which can be risky.
The new method uses a 'SNIT score' derived from routine blood tests and patient information.
Your medical treatment won't change if you participate.
Participation involves collecting your existing medical data, not extra tests or visits.
The goal is to make diagnosing INS safer and easier for patients in the future.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older. You must be in hospital because you're experiencing your first episode of a kidney condition called nephrotic syndrome. This means you have a certain level of protein in your urine and low levels of a protein called albumin in your blood.

An important part of joining the study is that a specific blood test, called the anti-PLA2r antibody test, must have come back negative. You also need to be someone who would normally require a kidney biopsy to figure out what's causing your symptoms.

However, you wouldn't be able to join if you already know that you have certain other kidney conditions, like lupus nephropathy or IgA nephropathy, before your current kidney problems started.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently in hospital for your first episode of nephrotic syndrome?
Have your specific blood tests (anti-PLA2r antibodies) for other kidney conditions come back negative?
Would your doctors usually recommend a kidney biopsy for you to find out your diagnosis?
Have you not been previously diagnosed with lupus nephropathy?
Have you not been previously diagnosed with IgA nephropathy?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your medical care for your kidney condition will continue as normal; the study won't change how your doctors treat you. You'll be given detailed information about the study and have a chance to ask any questions you have. If you agree to take part, your doctors will collect information they already gather as part of your care. This includes details like your age, sex, medical history, blood pressure, whether you have swollen legs, and the results from various blood and urine tests.

These details will be used to calculate the new diagnostic score (SNIT), but your doctor won't see this score during your hospital stay. About one month after you join the study, doctors will collect updated information from your medical records, such as how your kidney function is changing and what treatments you're receiving. The final diagnosis for your condition, which will usually come from your kidney biopsy results, will be collected once it's available, typically within four months. There are no extra hospital visits required specifically for the study, beyond your standard care.

Potential risks and benefits

The main benefit of this study is that it might help develop a safer, less invasive way to diagnose Idiopathic Nephrotic Syndrome in the future, potentially reducing the need for kidney biopsies. There are no direct medical risks from participating in the study itself, as it mainly involves collecting information from your routine care and no changes to your treatment. The study also aims to evaluate if there are any theoretical risks if a diagnosis is made incorrectly using the new score. Remember, you can choose to withdraw from the study at any time without affecting your medical care.

Locations (1)

Service de Néphrologie et Dialyses, Hôpital Tenon
Verified postcode
Paris, France· Recruiting

Common questions

What is Idiopathic Nephrotic Syndrome (INS)?

It's a kidney condition where your kidneys leak too much protein into your urine, which can cause swelling and other problems. 'Idiopathic' means doctors don't know the exact cause.

What is a kidney biopsy?

It's a medical procedure where a doctor uses a needle to take a small sample of your kidney for examination under a microscope. It helps diagnose kidney conditions but can have risks.

What is the SNIT score?

The SNIT score is a new diagnostic tool researchers developed. It uses information from your routine blood tests and medical records to try and diagnose INS without a biopsy.

Will my treatment change if I join the study?

No, your medical care and treatment will not be affected by taking part in this study. You will continue to be treated by your doctors as usual.

Do I have to have a kidney biopsy if I join this study?

To be in this study, you must be someone who would ordinarily need a kidney biopsy for your diagnosis. The study is testing if the SNIT score could replace it in the future, but for now, the biopsy is still the standard way to get a final diagnosis.

How to find out more

Alexandre LAHENS, Dr

alexandre.lahens@aphp.fr +33 1 56 01 70 43 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.