IgA Nephropathy Clinical Research Study

The ALIGN Study is testing atrasentan, an investigational medication, that has the potential to reduce protein in the urine and preserve kidney function in patients with immunoglobulin A nephropathy (IgAN).

Answer a few questions to see if you may qualify for the ALIGN Study.

Am I Eligible?

What is immunoglobulin A nephropathy (IgAN)?

IgAN, or IgA nephropathy, is a chronic kidney disease that occurs when a protein made by your immune system, called immunoglobulin A (IgA), builds up in your kidneys. This results in inflammation, tissue damage, and prevents the kidneys from performing their normal function – filtering blood. While IgAN can progress slowly, some patients are at risk of progressing to kidney failure and require dialysis or transplant within 10-20 years.

How is IgAN diagnosed?

One of the first possible signs of IgAN is blood or protein in your urine. Increased levels of protein in the urine is associated with a higher likelihood your disease may progress. When your doctor suspects that you have kidney problems, additional kidney function tests may be performed. However, the only way to diagnose IgAN is with a kidney biopsy. This procedure involves using a needle to collect a small sample of your kidney to be tested at a lab.

How is IgAN treated?

There is currently no cure for IgA nephropathy and limited treatment options. Medical management is primarily focused on treating the symptoms of the disease such as reducing blood pressure or suppressing the immune system. However, medications affecting the immune system can have serious side effects. Many patients with IgAN are on medicines called ACE inhibitors or ARBs. These medicines are sometimes used to treat high blood pressure too.

IgA Nephropathy and Atrasentan

The kidneys produce natural substances called endothelin, which play a role in blood pressure and body regulation. In certain conditions, such as IgA nephropathy, the kidney produces too much endothelin. These increased levels of endothelin can promote inflammation and scarring and play a role in the development of protein in the urine.

The study drug being investigated is Atrasentan. Atrasentan is an oral pill that will be taken once daily. Atrasentan works by blocking the higher levels of endothelin seen in IgA nephropathy patients and may be able to help prevent progressive damage to the kidneys.

Atrasentan has been tested in over 5,000 patients with diabetic kidney disease. In previous studies, researchers observed that atrasentan reduced the amount of protein in urine, preserved kidney function, and led to better clinical outcomes for patients with diabetic kidney disease. Important safety findings from these studies in patients with diabetic kidney disease included swelling of the legs (or other parts of the body) and weight gain from fluid retention.

The ALIGN study, sponsored by Chinook Therapeutics, is the first study to test atrasentan in patients with IgAN.

Atrasentan is an investigational agent and has not been approved for any uses, including in patients with IgA nephropathy.

doctor with patient

Am I Eligible?

Check all that apply.

  • I am at least 18 years of age.
  • I have been diagnosed with IgA nephropathy (IgAN) from a kidney biopsy.

You may be a potential fit for this study.

Next

About the Study

Before joining the ALIGN study, you will be screened to find out if you qualify to participate. If you qualify and choose to enroll, your participation in the Treatment and Follow-up periods of the study will last 136 weeks (about 2½ years). The study team will monitor your health through study-related tests and procedures at 18 scheduled study visits. These visits will be a combination of on-site clinic visits, remote visits (comprised of telemedicine and home health visits), and telephone calls. You will also need to complete some procedures on your own. The study team will explain all tests and procedures to you and provide detailed instructions for the procedures you complete on your own.
Clinical studies rely on the cooperation of volunteer participants. While you are taking part in this study, you will need to:

  • Follow instructions from the study doctor.
  • Attend all study visits. You may have the option to complete visits remotely or virtually.
  • Complete the tests and procedures that are part of the study, whether at study visits or on your own, as directed. Procedures will include 7 separate 24-hour urine collections.
  • Take the study drug or placebo once a day, as directed.
  • Keep track of when you take the study drug or placebo each day. You can record this information in your diary.
  • Check with your study doctor before changing any of your medications or starting any new medications.
  • Tell the study doctor about any changes to your health, even if you don't think they are important.
  • Tell the study doctor if you wish to stop being in the study.
  • Avoid getting pregnant or getting your partner pregnant.
The first step involves answering a few questions in an online prescreening questionnaire to see if you are a potential candidate for the study. Depending on your answers, you may be referred to a study clinic for screening.

Where is the study happening?

The ALIGN Study will be conducted across clinical sites in the Americas (Canada, US, Brazil, Argentina), Europe (France, United Kingdom, Italy, Spain, Germany, Poland) and Asia Pacific (China, Japan, Australia, New Zealand, India, South Korea, Hong Kong, Taiwan, Singapore). Study sites will continue to be added as we open the study. If you are unable to locate a site in your area and are willing to travel, reimbursement and support for travel to another site in your country may be available. Click a pin on the map or select a location from the list to view site information.

Clinical studies are how treatment options for diseases and health conditions are developed. These studies provide valuable information about safety and effectiveness before a study drug is approved.
Clinical studies follow a specific set of standards and are closely regulated to help protect study participants. An independent Ethics Committee or Institutional Review Board reviews and monitors each study closely to safeguard the rights and welfare of participants. Nevertheless, clinical studies have risks, including the potential to develop side effects. Although safety precautions are put in place to protect people who participate in clinical studies, your condition or health could remain the same, improve, or get worse. Any known risks and side effects will be discussed during the informed consent process, but there may be unknown risks.
The study drug is called atrasentan. Atrasentan has been tested in over 5,000 patients with diabetic kidney disease at the same dose that is being used in the ALIGN study. Atrasentan has not been tested in patients with IgA nephropathy.
If you qualify and choose to participate, you will be randomly (like the flip of a coin) assigned to receive either:

  • The study drug (about half the people)
    OR
  • Placebo (also about half the people)

Regardless of which study treatment you are assigned to, you will continue receiving standard of care treatment and continue taking your regular dose of a ACE inhibitor or ARB throughout the study. As well, all patients, including those assigned to placebo, may be offered one year of treatment with atrasentan after completing the ALIGN study.
In the ALIGN study, the study drug will be compared with a placebo to see if taking the study drug is better than taking the placebo. The placebo looks like the study drug but has no drug or other active ingredient in it.
Where allowed by local regulations, you may be compensated for your time spent collecting 24-hour urine samples and may be reimbursed for out-of-pocket expenses associated with your study participation, such as travel costs, the cost for contraception, or other out-of-pocket costs directly related to your participation in the trial.
You can stop taking study medication or leave the study at any time, for any reason. This will not otherwise affect the care you receive. Your study doctor will want to find out if you are having any side effects. The doctor can talk to you about other treatment options if you decide to leave the study.
You will continue receiving standard of care and taking your regular dose of ACEi/ARB throughout the study. You may need to stop taking some other medications during the study. The study doctor will discuss this with you in detail.
You can visit any doctor to meet your health needs during a study. You should tell other medical professionals you see that you are participating in a clinical study and always communicate openly with the study doctor regarding other care you receive.
At study visits, you will have tests and procedures that may include some or all of the following:
  • Physical exams
  • Blood draws
  • Urine testing
  • Electrocardiograms (ECGs)
  • Surveys about how you are feeling and about any side effects
You will talk with the study doctor about taking the study drug or placebo daily, taking other medications, avoiding pregnancy for you or your partner, and other study-related issues. Your study drug or placebo may be provided at visits or, where allowed, may be delivered to you.
If you choose to participate in the ALIGN study, we encourage you to communicate freely with the study doctor throughout the study.

If you have additional questions related to the ALIGN study, use the contact form at the top of the page and we will reply shortly.