Roxadustat (FG-4592) Versus Epoetin Alfa for Anemia in Patients Receiving Maintenance Hemodialysis: A Phase 2, Randomized, 6- to 19-Week, Open-Label, Active-Comparator, Dose-Ranging, Safety and Exploratory Efficacy Study

Provenzano, Robert; Besarab, Anatole; Wright, Steven; Dua, Sohan L.; Zeig, Steven; Nguyen, Peter; Poole, Lona; Saikali, Khalil G.; Saha, Gopal Chandra; Hemmerich, Stefan; Szczech, Lynda A.; Yu, K-H; Neff, Thomas B.

doi:10.1053/j.ajkd.2015.12.020

Cited by 216 publications

(282 citation statements)

References 33 publications

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“…Common documented side effects were diarrhea, headache, back pain, fatigue, and increases in blood pressure and liver enzymes [3,4,7]. Cardiovascular events were comparable in patients who received roxadustat compared to EPO analog; however, larger trials must be conducted to confirm these results [7].…”

Section: Adverse Eventsmentioning

confidence: 99%

“…Roxadustat offers a novel way of utilizing the body's natural compensatory mechanisms in response to hypoxia [3,4,7]. Hypoxia-inducible factors (HIF) are transcription factors that regulate expression of genes that stimulate erythropoiesis.…”

Section: Pharmacodynamicsmentioning

confidence: 99%

“…Roxadustat is orally bioavailable with an estimated half-life of 12 h [7]. In a placebo-controlled dose-ranging study (NCT00761657), selected patients who were being studied for treatment efficacy of roxadustat in NDD-CKD were also evaluated for pharmacokinetic and pharmacodynamics parameters [4].…”

Section: Pharmacokineticsmentioning

confidence: 99%

“…Anemia Treatment in Patients with Dialysis-Dependent CKD who Previously had Hb Levels Maintained with Epoetin Alfa A phase II, randomized, open-label, dose-ranging, active control study (NCT01147666) evaluated the safety and efficacy of roxadustat in maintaining Hb levels in patients on maintenance dialysis therapy, and who had maintained Hb levels with the IV EPO analog, epoetin alfa [7]. The study also evaluated the optimum starting dose and dose adjustment regimens of roxadustat in this patient population.…”

Section: Therapeutic Trialsmentioning

confidence: 99%

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A New Approach to the Management of Anemia in CKD Patients: A Review on Roxadustat

Becker

Saad

2017

Adv Ther

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This article informs the reader of the current information available on a novel therapeutic agent and new class of drug for the treatment of anemia. The data show promising results for alternative erythropoietin-stimulating agents and offers a time line of when Phase III data will be available. The information on this new drug and new drug class will change how nephrologists approach treating anemia within their patients.

show abstract

Section: Adverse Eventsmentioning

confidence: 99%

Section: Pharmacodynamicsmentioning

confidence: 99%

Section: Pharmacokineticsmentioning

confidence: 99%

Section: Therapeutic Trialsmentioning

confidence: 99%

See 2 more Smart Citations

A New Approach to the Management of Anemia in CKD Patients: A Review on Roxadustat

Becker

Saad

2017

Adv Ther

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“…The only serious adverse event considered as possibly related to roxadustat was an episode of acute pancreatitis; however, both the sponsor and the independent data monitoring committee considered it unrelated because of a possible alternative cause [50].…”

Section: Roxadustat (Fg-4592/asp1517)mentioning

confidence: 99%

HIF stabilizers in the management of renal anemia: from bench to bedside to pediatrics

Kular

Macdougall

2018

Pediatr Nephrol

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Anemia is a common complication of chronic kidney disease (CKD) in adult and pediatric patients. It has traditionally been treated with erythropoietin therapy and iron supplementation, with great success. With the discovery of the major transcription factor hypoxia inducible factor (HIF) for the erythropoietin gene in 1992, molecules were created that inhibit the HIF prolylhydroxylase enzyme. This new class of drug-called HIF stabilizers, or HIF prolyl-hydroxylase inhibitors-prevents the proteasomal degradation of HIF-α, thereby inducing upregulation of the erythropoietin gene. This new strategy for treating CKD anemia is already in phase III clinical trials in adults, and the potential advantages of this therapy are that it is orally active (thereby avoiding injections), and patients are exposed to lower circulating levels of erythropoietin. The long-term safety of this strategy, however, requires elucidation in these trials, particularly since there are many other hypoxia-sensitive genes, notably, angiogenic factors such as vascular endothelial growth factors (VEGF), as well as glycolytic enzymes. As with all new therapies, it is only once a positive benefit: risk profile has been ascertained in adults that the treatment will translate across into pediatrics. Specific issues in the pediatric CKD population are discussed in this review.

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Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease

Natale

Palmer

Jauré

et al. 2022

Cochrane Database of Systematic Reviews

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Roxadustat (FG-4592) Versus Epoetin Alfa for Anemia in Patients Receiving Maintenance Hemodialysis: A Phase 2, Randomized, 6- to 19-Week, Open-Label, Active-Comparator, Dose-Ranging, Safety and Exploratory Efficacy Study

Abstract: In this phase 2 study of anemia therapy in patients with end-stage renal disease on maintenance hemodialysis therapy, roxadustat was well tolerated and effectively maintained Hb levels.

Cited by 216 publications

References 33 publications

A New Approach to the Management of Anemia in CKD Patients: A Review on Roxadustat

A New Approach to the Management of Anemia in CKD Patients: A Review on Roxadustat

HIF stabilizers in the management of renal anemia: from bench to bedside to pediatrics

Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease

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