Active not recruitingPHASE2INTERVENTIONAL

Atrasentan in Patients With Proteinuric Glomerular Diseases

The AFFINITY study is testing a new medication called atrasentan for people with specific kidney problems that involve too much protein in their urine. These conditions include IgA nephropathy, Alport syndrome, focal segmental glomerulosclerosis (FSGS), and diabetic kidney disease. The main goal is to find out if atrasentan can lower the amount of protein in the urine, which is a sign of kidney damage. Researchers also want to check how safe the medicine is and if it helps keep kidney function stable over time. About 100 people will take part, receiving atrasentan daily for about a year, with a chance to continue treatment for longer. The study will help us understand if this medicine could be a good treatment option for these kidney conditions.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

103

Start

15 Mar 2021

Estimated completion

27 Oct 2026

IgA Nephropathy Focal Segmental Glomerulosclerosis Alport Syndrome Diabetic Kidney Disease Diabetic Nephropathy Type 2 Immunoglobulin A Nephropathy

What is this study about?

This study, called AFFINITY, is looking into a new medication named atrasentan. It's being tested for people who have certain kidney diseases where their kidneys are leaking too much protein into their urine. This 'protein leak' can be a sign that the kidneys are not working as well as they should and might get worse over time. The study wants to see if atrasentan can help to reduce this protein and protect the kidneys.

The study includes several different groups of people, known as 'cohorts,' each with a specific kidney condition. These include IgA nephropathy, focal segmental glomerulosclerosis (FSGS), Alport syndrome, and diabetic kidney disease. By including different groups, researchers can learn how atrasentan might work across various kidney problems. The main things they're looking for are whether the amount of protein in the urine decreases, and how safe the medicine is for patients. They will also keep an eye on overall kidney function.

Finding new ways to treat these kidney conditions is really important. If atrasentan proves to be effective and safe, it could offer a new treatment option that helps slow down kidney damage and improve people's health. The study is currently in Phase 2, which means it's testing the medicine in a larger group of people to get a better idea of its effects and to confirm its safety before it might move on to even larger studies.

Key takeaways

The AFFINITY study is testing a new medicine called atrasentan for various kidney diseases.
It aims to reduce protein in the urine and preserve kidney function.
Participants will take atrasentan daily for at least a year, potentially longer.
The study includes distinct groups of patients, such as those with IgA nephropathy and diabetic kidney disease.
Regular health checks, including blood and urine tests, will monitor your progress and safety.
Remote visits might be an option to make participation easier.

Who may be eligible?

To join this study, generally, you need to be an adult, aged 18 or older. For those with diabetic kidney disease, you'd need to be between 18 and 70. You should also be taking a stable dose of certain kidney protection medicines, like ACE inhibitors or ARBs, for at least three months.

There are specific requirements depending on your kidney condition. For example, if you have IgA nephropathy, your kidney biopsy needs to confirm this, and your protein levels and kidney function (eGFR) must be within certain ranges. Similar specific criteria apply to people with FSGS, Alport syndrome (confirmed by genetic testing), and diabetic kidney disease.

Some things would mean you couldn't take part. This includes having other serious kidney diseases, having had a kidney transplant, or having certain heart conditions like a history of heart failure. You also wouldn't be able to join if your blood pressure or hemoglobin levels are too high or too low, or if you have a current diagnosis of cancer. The study team will review all your medical information carefully to see if you're a good fit.

Quick self-check

Are you 18 years or older (or 18-70 if you have diabetic kidney disease)?
Have you been diagnosed with IgA nephropathy, FSGS, Alport syndrome, or diabetic kidney disease?
Are you currently taking common kidney protection medicines (like ACE inhibitors or ARBs) and have been on a stable dose for at least 3 months?
Do you have certain levels of protein in your urine and your kidney function (eGFR) is not too low?
Have you NOT had a kidney transplant or been diagnosed with heart failure?
Do you NOT have blood pressure that is too high or very low hemoglobin levels?

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

What does participation involve?

If you join the study, you'll take the medicine atrasentan, usually as a pill once a day, for about a year (52 weeks). Some people with FSGS might have their dose increased if the lower dose is well tolerated. After this initial period, you might have the option to continue taking the medicine for up to an additional 84 weeks, meaning a total of up to 188 weeks (nearly 3.5 years) of treatment.

Throughout the study, you'll have regular check-ups. These visits will involve blood tests, urine tests to measure protein levels, and checks of your kidney function and overall health. Some of these visits might be done remotely, like through video calls or with a home healthcare nurse, if it's allowed where you live. This helps make it easier for you to take part without always having to travel to the clinic.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that atrasentan might help reduce protein in your urine and slow down the progression of your kidney disease. However, there's no guarantee it will work for everyone, and it might not help you personally. As with any medication, there's a chance of side effects, which the study team will monitor closely. You'll receive careful medical supervision throughout the study, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (33)

Kidney Disease Medical Group
Glendale, United States
Academic Medical Research Institute
Los Angeles, United States
North America Research Institute
San Dimas, United States
Stanford U School Of Medicine
Stanford, United States
Colorado Kidney Care Nephrology
Denver, United States
Northwest Louisiana Nephrology Research
Shreveport, United States
Tufts Medical Center
Boston, United States
Uni of Minnesota Hos and Clinics
Minneapolis, United States
DaVita Clinical Research
Las Vegas, United States
Mountain Kidney And Hyper Associa
Asheville, United States
Brookview Hills Research Assoc
Winston-Salem, United States
Baylor Scott and White
Dallas, United States

+21 more sites — see the official record for the full list.

Common questions

What is atrasentan?

Atrasentan is a new investigational medicine being tested to see if it can help people with certain kidney diseases by reducing protein in their urine.

Why is it important to reduce protein in the urine?

Too much protein in the urine can be a sign of kidney damage and may mean your kidney disease could get worse over time. Reducing it might help protect your kidneys.

How long will I take the medicine?

You will take the study medicine for about a year, with the possibility of continuing for up to another 84 weeks if it's working well and you're tolerating it.

Will I have to pay for the study medicine or visits?

No, all study-related visits, tests, and the medicine itself are provided free of charge if you participate in a clinical trial.

Can I leave the study at any time?

Yes, you are free to leave the study at any time, for any reason, without affecting your medical care.