Trials reveal efficacy and safety of oral drug for treating anemia
associated with kidney disease

Date:
August 6, 2021
Source:
American Society of Nephrology
Summary:
Pooled results from phase 3 clinical trials demonstrate that
roxadustat is efficacious and may be comparable to placebo in
studies done to date for treating anemia in patients with chronic
kidney disease who do not require dialysis.



FULL STORY ========================================================================== Pooled results from recent clinical trials indicate that an oral drug
called roxadustat is an effective treatment for anemia in patients with
chronic kidney disease. The results are published in an upcoming issue
of CJASN.


==========================================================================
Many individuals with kidney dysfunction develop anemia, or a shortage
of healthy red blood cells that carry oxygen to the body's tissues. Some treatments for anemia are linked with serious cardiovascular side effects,
but a new class of oral drugs called hypoxia inducible factor-prolyl hydroxylase inhibitors may be comparable to placebo in these trials. These drugs act on the pathway involved in the production of erythropoietin
that stimulates red blood cell formation.

To evaluate the efficacy and cardiovascular safety of one such inhibitor
- - called roxadustat -- Robert Provenzano, MD (Wayne State University
School of Medicine) and his colleagues analyzed data pooled from three
phase 3 studies of roxadustat in patients with chronic kidney disease
and anemia.

In total, 2,391 patients received roxadustat and 1,886 received a placebo.

Roxadustat treatment boosted levels of hemoglobin (the protein in
red blood cells responsible for transporting oxygen): roxadustat-
vs. placebo-treated patients showed an average change in hemoglobin
averaged over weeks 28 to 52 of 1.9 vs. 0.1 g/dL. Roxadustat also reduced
the need for red blood cell transfusions in the first 52 weeks, and there
were no increased risks of mortality, heart attacks, strokes linked to
the drug.

"Roxadustat was shown to be effective, with an acceptable safety
profile," said Dr. Provenzano. "As an oral agent, roxadustat addresses
the significant unmet need in treating anemia in patients with kidney
disease." Study co-authors include Lynda Szczech, MD, Robert Leong,
MD, Khalil Saikali, MD, Ming Zhong, PhD, Tyson T. Lee, PhD, Dustin
J. Little, MD, Mark T, Houser, MD, Lars Frison, PhD, John Houghton,
and Thomas B. Neff, MD.

Disclosures: RP serves as a consultant for AstraZeneca, DaVita, and
FibroGen.

LS, RL, KGS, MZ, TTL are employees of FibroGen and hold stock and/or stock options in FibroGen. MTH, LF, DJL, and JH are employees of AstraZeneca
and hold stock and/or stock options in AstraZeneca.

========================================================================== Story Source: Materials provided by American_Society_of_Nephrology. Note: Content may be edited for style and length.


========================================================================== Journal Reference:
1. Robert Provenzano, Lynda Szczech, Robert Leong, Khalil G. Saikali,
Ming
Zhong, Tyson T. Lee, Dustin J. Little, Mark T. Houser, Lars
Frison, John Houghton, Thomas B. Neff. Efficacy and Cardiovascular
Safety of Roxadustat for Treatment of Anemia in Patients with
Non-Dialysis- Dependent CKD. Clinical Journal of the American
Society of Nephrology, 2021; 16 (8): 1190 DOI: 10.2215/CJN.16191020 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2021/08/210806171916.htm

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