Active not recruitingPHASE3INTERVENTIONAL

Atrasentan in Patients With IgA Nephropathy

This research study, called ALIGN, is looking at a new medicine called atrasentan for people with a kidney condition known as IgA nephropathy. In this condition, the kidneys become damaged over time. The study aims to find out if atrasentan can help to protect the kidneys better than a dummy pill (placebo). Participants will take either atrasentan or the placebo daily for about two and a half years. Doctors will carefully check changes in their kidney function and overall health. The study is particularly interested in how the medicine affects protein in the urine, which is a sign of kidney damage, as well as how it impacts kidney function over time and quality of life. This is a "Phase 3" study, meaning the medicine has already been tested in earlier stages.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

404

Start

11 Dec 2020

Estimated completion

14 Apr 2028

IgA Nephropathy Immunoglobulin A Nephropathy

What is this study about?

This study is investigating a new medicine called atrasentan for people who have a kidney disease known as IgA nephropathy, sometimes shortened to IgAN. In IgA nephropathy, the kidneys become damaged, which can lead to them not working as well over time. The main goal of this study is to see if atrasentan can help slow down this damage and protect the kidneys.

To find this out, about 320 people with IgA nephropathy will be split into two groups. One group will take atrasentan, and the other group will take a dummy pill (called a placebo) every day for over two years. Neither the participants nor their doctors will know who is getting the actual medicine and who is getting the placebo. This helps make sure the results are fair. Everyone in the study will also receive the standard care for their kidney condition, which often includes other blood pressure lowering medications.

Throughout the study, doctors will closely monitor various aspects of participants' health. They will particularly look at the amount of protein in the urine, which is a key sign of kidney damage, and how well the kidneys are filtering waste. They will also check for any side effects of the medicine and how it affects people's overall quality of life. At the end of the main study, some participants might have the option to continue taking atrasentan in a follow-up part of the study.

Key takeaways

This study is for people with IgA nephropathy.
It tests a new medicine called atrasentan against a dummy pill.
Participants will follow the study for about 2.5 years, taking a daily pill.
The aim is to see if atrasentan can protect kidneys and slow disease progression.
Regular health checks and monitoring will be part of the study.

Who may be eligible?

To join this study, you generally need to be at least 18 years old and have a confirmed diagnosis of IgA nephropathy from a kidney biopsy. You should also be taking a stable, maximum dose of a common type of blood pressure medicine for kidney protection (like an ACE inhibitor or ARB) for at least 12 weeks. If you can't take these specific medicines, you might still be able to join.

Important health checks include having at least 1 gram of protein in your urine per day and your kidney function (eGFR) should be 30 mL/min or higher. You'll also need to be willing to follow all study instructions and, if you're a fertile man or a woman who could become pregnant, agree to use effective contraception during and for a short time after the study.

You cannot join if you have another significant kidney disease, a severe condition called nephrotic syndrome, certain heart problems (indicated by a high BNP level), or very low blood platelet counts. Your doctor will be able to check all these details for you.

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 at least 18 years old?
Do you have a biopsy-confirmed diagnosis of IgA nephropathy?
Are you currently taking a stable dose of an ACE inhibitor or ARB (or unable to tolerate them)?
Do your urine tests show at least 1 gram of protein per day?
Is your kidney function (eGFR) at least 30 mL/min?
Are you able to use effective contraception if needed?

Answer every question to see your result.

What does participation involve?

If you join, you'll take either atrasentan or a dummy pill once a day for about two and a half years (132 weeks). You'll have regular visits to the clinic for check-ups, which include blood tests, urine tests, and discussions about your health and any side effects. These visits will help doctors monitor the medicine's effect on your kidneys and your overall well-being.

Some of these visits might be possible from home using video calls or home health services, depending on local rules, to make it easier for you. After the main two and a half years, if you complete the study, you might have the opportunity to take atrasentan for another 48 weeks in an ‘open-label’ part of the study, meaning everyone would know they are getting the active medicine. The full study duration, including any extended part, could last up to approximately 3 years.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new medicine that could help slow down your kidney disease, getting closer monitoring of your health, and contributing to medical knowledge that could help others. However, like all medicines, atrasentan might have side effects, which the study team will discuss with you. There's also a chance you could receive the dummy pill, meaning you wouldn’t get the potential benefits of the active drug. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (135)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
Comprehensive Research Institute
Verified postcode
Alhambra, United States
Kidney Disease Medical Group
Verified postcode
Glendale, United States
Stanford University
Verified postcode
Stanford, United States
University of Florida
Verified postcode
Gainesville, United States
GA Nephrology Associates
Verified postcode
Lawrenceville, United States
NANI Research, LLC
Verified postcode
Hinsdale, United States
NANI Research, LLC
Verified postcode
Fort Wayne, United States
University of Louisville Physicians- Kidney Disease Program
Verified postcode
Louisville, United States
Tufts Medical Center
Verified postcode
Boston, United States
Intermed Consultants
Verified postcode
Minneapolis, United States
Pelican Point Dialysis - DaVita Clinical Research
Verified postcode
Las Vegas, United States

Common questions

What is IgA nephropathy?

IgA nephropathy is a long-term kidney disease where a specific antibody (IgA) builds up in the kidney filters, causing damage and leading to a gradual loss of kidney function over time.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the new medicine against what happens when people think they are getting treatment.

How long will the study last?

The main part of the study where you take the medicine or dummy pill will last about two and a half years (132 weeks). There might be an option to continue for another 48 weeks after that.

Will I know if I'm getting the medicine or the placebo?

No, during the main part of the study, neither you nor your study doctor will know whether you are taking atrasentan or the placebo. This is called 'double-blind' and helps ensure fair results.

Can I stop participating in the study at any time?

Yes, you are free to leave the study at any point without needing to give a reason, and it will not affect your ongoing medical care.