In late October, the American Society of Nephrology (ASN) held the ASN Kidney Week 2020 Reimagined. During the conference, biopharmaceutical company FibroGen shared two posters (abstracts PO2625 and PO2626) regarding roxadustat for patients with anemia of chronic kidney disease (CKD). According to a press release, these presentations centered around data from a Phase 3 development program. Interested in seeing the abstracts? Take a look at the ASN Kidney Week website.

Roxadustat

Developed for use in patients with anemia of CKD, Roxadustat is an orally-administered HIF-PH inhibitor. This first-in-class treatment helps prompt the production and growth of red blood cells. Additionally, Roxadustat helps patients absorb and transport iron, and reduce or inhibit inflammation. In addition to its current use, the therapy is also being developed for patients with chemotherapy-induced anemia and anemia related to myelodysplastic syndromes (MDS). Currently, Roxadustat is not yet approved in the United States; however, there should be a full review by the end of the year. In other areas of the world:

• Roxadustat was accepted for review in Europe early in 2020.
• It is approved in China to treat adult patients with anemia of CKD. These patients can be on dialysis, but it is also approved for patients not using dialysis.
• In Japan, Roxadustat can be used to treat patients on dialysis. However, it is still under regulatory review to determine if it can be used for patients not on dialysis.

To determine the efficacy of Roxadustat, researchers analyzed data sourced from two separate analyses. These analyses focused on two sets of patients: those on dialysis and those not on dialysis. Researchers determined that hemoglobin levels under 8 g/dL were most dangerous for both groups in terms of heart failure, stroke, fatality, or other potential complications. When hemoglobin levels were over 10 g/dL, the risk of complications significantly fell.

Since Roxadustat is able to increase and maintain hemoglobin levels, it offers a promising treatment for patients with anemia of CKD. The therapy reduces the risk of cardiovascular issues. It was also found to be relatively safe, effective, and well-tolerated.

Chronic Kidney Disease (CKD)

Also known as chronic kidney failure, chronic kidney disease (CKD) is long-lasting kidney damage that grows progressively worse. An estimated 26 million Americans have CKD. Normally, healthy kidneys filter fluid and waste from the blood, which is excreted during urination. However, CKD prevents this from happening. As a result, fluids, electrolytes, and waste accumulate in the body. An estimated 20% of patients with CKD experience anemia, or low red blood cell and hemoglobin levels. This is called anemia of CKD. Patients with anemia of CKD are at a higher risk of being hospitalized, typically have lower quality of life (QOL), and often require blood transfusions or other medical interventions.

CKD typically occurs in conjunction with another condition, such as diabetes, pyelonephritis, polycystic kidney disease, or urinary tract obstruction. Symptoms include:

• Nausea
• Appetite loss
• Jaundice
• Poor growth and development
• Pruritis (intense itching)
• Fatigue
• Spleen and liver enlargement
• High blood pressure
• Changes in urination
• Muscle cramping
• Swelling of the lower extremities
• Shortness of breath / difficulty breathing

Learn more about CKD.