Roxadustat Significantly Increased Hemoglobin Levels for Chronic Kidney Disease Patients with Anemia in Phase III OLYMPUS and ROCKIES Trials

AstraZeneca today presented detailed results from the Phase III OLYMPUS and ROCKIES trials showing that roxadustat significantly increased hemoglobin (Hb) levels in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients with anemia from chronic kidney disease (CKD), respectively.

The OLYMPUS trial compared roxadustat to placebo while the ROCKIES trial compared roxadustat to epoetin alfa. The results were presented today during two oral sessions at the American Society of Nephrology (ASN) Kidney Week 2019 in Washington, D.C.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Anemia is a common, serious condition among patients with chronic kidney disease. It occurs when the body has fewer healthy red blood cells than normal and low levels of hemoglobin, which may leave patients fatigued and short of breath. Results from OLYMPUS and ROCKIES reinforce the potential role that roxadustat could play in increasing hemoglobin levels and managing anemia, which is often underdiagnosed and undertreated.”

Steven Fishbane, MD, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, US and primary investigator on the OLYMPUS and ROCKIES trials, said: “These data demonstrated that roxadustat effectively increased hemoglobin levels for patients with anemia from chronic kidney disease, including those who show signs of inflammation. Patients who experience chronic inflammation are often more difficult to treat than the overall chronic kidney disease patient population, emphasizing the need for new treatment options.”

In the OLYMPUS trial, roxadustat demonstrated a statistically significant improvement in Hb levels from baseline, with a mean increase of 1.75g/dL averaged over weeks 28 to 52, compared to 0.40g/dL with placebo, the primary efficacy endpoint.

Roxadustat also improved Hb levels from baseline in a subgroup of patients with elevated high-sensitivity C-reactive protein (hsCRP) levels of greater than 5 mg/L, with a statistically significant mean increase of 1.73g/dL, compared to 0.62g/dL with placebo, a secondary endpoint. hsCRP is a protein in the blood that increases when inflammation is present.

Overall safety findings are generally consistent with the NDD-CKD patient population. For all patients, the most frequently reported adverse events in the intent to treat analysis set were end-stage renal disease, pneumonia, urinary tract infection and hypertension. Additional serious adverse events reported were azotemia, sepsis, acute kidney injury and hyperkalemia.