Since its conception, biotechnology company Chinook Therapeutics, Inc. (“Chinook”) has worked to develop therapeutic solutions for patients with kidney diseases. Now, the company enrolled the first patient in a Phase 3 ALIGN clinical trial. During the trial, researchers will evaluate the safety and efficacy of atrasentan for patients with IgA nephropathy (IgAN).
Atrasentan
In prior studies, atrasentan was shown to reduce proteinuria (excess protein in the urine) and improves estimated glomerular filtration rate (eGFR). The National Kidney Foundation describes eGFR as:
the best test to measure your level of kidney function and determine your stage of kidney disease.
Now, researchers are looking to evaluate whether atrasentan could have anti-inflammatory and anti-fibrotic impact for patients with IgA nephropathy. Currently, no approved treatments exist for this condition. Thus, atrasentan represents the potential to fill an unmet need. Chinook describes atrasentan as:
a potent and selective, small molecule inhibitor of the endothelin A receptor for the potential treatment of IgA Nephropathy (IgAN) and other proteinuric glomerular diseases.
In the Phase 3 ALIGN trial, researchers will evaluate atrasentan for patients with IgAN as compared to a placebo. Altogether, 320 patients will enroll. For a 2.5 year period, patients will receive either orally administered 0.75mg atrasentan or a placebo. During the trial, researchers aim to understand the drug’s safety, efficacy, tolerability, and effect on proteinuria. Additionally, researchers want to determine whether the drug could improve patients’ quality of life (QOL). Data from the trial should be available in 2023.
IgA Nephropathy (IgAN)
Also known as Berger’s disease, IgA nephropathy (IgAN) is a form of chronic kidney disease (CKD) which may progress to kidney failure. Normally, we have an antibody in our bodies called IgA. This helps to protect the body from foreign invaders. However, when too much IgA accumulates in the kidneys, it causes inflammation and prevents the kidneys from effectively removing waste from the body. In many cases, IgAN occurs after an upper respiratory or gastrointestinal infection. Males are 2x more likely to have IgAN than females. While IgAN typically manifests during teenage years, many people remain asymptomatic until later stages. Up to 40% of patients develop end-stage kidney disease within 20 years of developing IgAN. Before that, if symptoms appear, they include:
- Proteinuria
- Bloody urine
- Back and groin pain
- Edema in the hands and feed (swelling caused by fluid under the skin)
- High blood pressure
- Drowsiness
- Kidney failure
- Itchiness
- Nausea and vomiting
- Appetite loss
- Unintended weight loss
- Difficulty concentrating
