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.
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.
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.
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.
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.
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