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An open-label extension study to evaluate the efficacy and safety of Roxadustat for the long-term maintenance treatment of anemia in dialysis and non-dialysis patients with CKD


Category: Anemia and Iron Metabolism: Clinical  

Authors: Chao H. Sun MD, FASN; Elizabeth A. Barranco MD; Lona Poole, MD; Meraf Eyassu RN; Cameron S. Liu PhD; Donna L. Kline; Thomas B. Neff; Kin-Hung Peony Yu, MD

Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulates erythropoiesis by increasing erythropoietin, and regulates iron metabolism.

An open-label, extension study originally included 14 subjects with non-dialysis-dependent chronic kidney disease (NDD-CKD) and 1 subject with dialysis-dependent chronic kidney disease (DD-CKD). After enrollment, 2 of the subjects ended up being excluded from analyses – one with NDD-CKA withdrew consent two weeks post-enrollment and one with DD-CKD was excluded.

These subjects completed the treatment period of a phase II roxadustat anemia study, were enrolled is this extension study and continued taking roxadustat at the same dosage and frequency, unless a dose adjusting was absolutely necessary. These were followed by dose titration to Hb levels.

Assessed were mean Hb values, total weekly roxadustat doses and dose frequencies over time, as well as safety and tolerability by adverse events, vital signs, echocardiogram findings, and clinical laboratory values.

In the 13 NDD-CKD patients, the mean age was 65.5 years, with a range of 38-78 years. 61.5% of the subjects were female (8/13) and all were white. Baseline Hb levels were 10.2 g/dL on average and eGFR were 26.1 mL/min on average. Upon enrollment, 1 out of 13 subjects, or 7.7%, were on TWI dosing regimen, 69.2%, or 9 out of 13 were on BIW, and 23.1, or 3 out of 13, were on QW.

The mean follow-up in these subjects was 3.7 years and over time, Hb levels averaged 11.7 g/dL.

At the last dose, 7.7%, or 1 out of 13 of subjects were on TIW dosing, 69.2%, or 9 out of 13 were on BIW, 15.4%, or 2 out of 13 were on QW, and 7.7%, or 1 out of 13 were on QOW dosing regimen. Roxadustat mean total weekly doing was 241.2 mg. *Safety and tolerability profiles observed during this study were expected for the population of this patient base.

According to the results of this study, for patients with NDD-CKD on long-term use of roxadustat treatment for anemia demonstrated “continued efficacy in Hb maintenance in all patients with a safety profile consistent” with this patient population.  

“The true significance of this study was that it was the first long-term study of its kind with shown efficacy over 336 months or 6.4 years,” explained Lynda Szczech, M.D., MSCE, VP, Clinical Development at FibroGen.

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