Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects with IgA Nephropathy on Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) (The ASSIST study)

This study, called ASSIST, is investigating a new medicine named atrasentan for people who have a kidney disease called IgA nephropathy. Participants in the study are already taking a different type of kidney medicine called an SGLT2 inhibitor (like dapagliflozin). The main goal is to see if adding atrasentan helps to reduce the amount of protein in their urine over 12 weeks, which is a sign of improved kidney health. The study uses a 'crossover' design, meaning participants will take both atrasentan and a dummy pill (placebo) at different times, so we can compare their effects carefully. This is a Phase II study, meaning it's an early-stage study to understand if the medicine works and is safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Novartis Pharma AG

Enrolment target

Start

30 Oct 2023

Nephrology

What is this study about?

This study is looking into a condition called IgA nephropathy. This is a kidney disease where the body's immune system damages the filters in the kidneys, which can lead to protein leaking into the urine. Over time, this can make the kidneys less able to do their job properly.

The study wants to find out if a new medicine, atrasentan, can help people with IgA nephropathy. Many people with this condition might already be taking other medicines, such as SGLT2 inhibitors (like dapagliflozin), which are known to help protect the kidneys. This research aims to see if adding atrasentan to their current treatment makes an even bigger difference in reducing the amount of protein in their urine.

The study is designed to be very careful. It's 'randomized,' meaning participants are put into groups by chance, and 'double-blind,' so neither the patients nor their doctors know who is getting the real medicine and who is getting a dummy pill (placebo). It's also a 'crossover' study, so at different times, participants will get both the medicine and the placebo. This helps researchers compare the treatments thoroughly and ensures any changes are really due to the medicine.

Key takeaways

This study evaluates a new medicine, atrasentan, for IgA nephropathy.
It aims to reduce protein in the urine, a sign of kidney health.
Participants already take an SGLT2 inhibitor kidney medicine.
The study compares atrasentan to a dummy pill (placebo) in a careful way.
It's for adults aged 18 and over with IgA nephropathy.
Patient safety and the right to withdraw are top priorities.

Who may be eligible?

This study is looking for adults aged 18 and over, with no upper age limit. Both men and women can take part.

You would need to have been diagnosed with IgA nephropathy and already be taking an SGLT2 inhibitor medication, such as dapagliflozin, as part of your treatment.

While the exact details of who can and cannot join will be discussed thoroughly with the study team, typically, people with certain other health conditions or those taking specific medications might not be suitable for this type of research. This is to ensure the study is safe and the results are clear.

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.

Am I 18 years old or older?
Do I have a diagnosis of IgA nephropathy?
Am I currently taking an SGLT2 inhibitor medication (like dapagliflozin)?
Am I willing to attend regular clinic appointments and provide samples?
Am I comfortable with not knowing if I'm receiving the active medicine or a dummy pill?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you meet all the requirements. If you do, the study involves taking either the study medicine (atrasentan) or a dummy pill (placebo) for certain periods. Because it's a 'crossover' study, you will get a chance to take both at different times.

You would need to attend regular clinic visits, typically over several months. During these visits, the study team would check your health, take blood and urine samples (including 24-hour urine collections to measure protein levels), and review any effects you might be experiencing. All of these checks help the researchers understand how the medicine is working and ensure your safety. You would continue to take your usual SGLT2 inhibitor medication throughout the study.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of this study is that atrasentan might help to reduce protein in your urine, which could improve your kidney health. However, there's no guarantee, and the dummy pill may not have any effect. Potential risks include side effects from the study medicine, which will be fully explained by the study team. You might also experience discomfort from blood tests or collecting urine samples. Your safety and well-being are paramount, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is IgA nephropathy?

IgA nephropathy is a kidney disease where the body's immune system causes damage to the kidneys, leading to protein leaking into the urine.

What is an SGLT2 inhibitor?

SGLT2 inhibitors are a type of medicine, like dapagliflozin, that help the kidneys remove sugar from the body, and they are also used to protect the kidneys in conditions like IgA nephropathy.

What does 'crossover study' mean?

It means you will take both the experimental medicine and a dummy pill (placebo) at different times during the study, allowing researchers to compare their effects on you.

What is a '24-hour urine collection'?

This is where you collect all your urine over a full day and night. It helps doctors measure the amount of protein your kidneys are letting through.

Will I know if I'm getting the real medicine or the dummy pill?

No, this is a 'double-blind' study, meaning neither you nor your doctor will know who is getting which treatment. This helps ensure fair and unbiased results.