FDA Panel Rejects Roxadustat for Anemia in Kidney Disease FDA Panel Rejects Roxadustat for Anemia in Kidney Disease
An FDA advisory committee voted by 1-13 and 2-12 margins against approving a novel, oral agent, roxadustat, for treating anemia in patients with chronic kidney disease. Safety was the major issue.Medscape Medical News
ConclusionsThis case suggests that iron-overload mechanisms of dyserythropoietic anemias may apply to megaloblastic anemias.
ConclusionRoxadustat was non-inferior to ESAs in maintaining hemoglobin levels in this cohort of patients with anemia of CKD on dialysis for at least 4 months who were previously treated with ESAs. Observed TEAEs were consistent with previous studies.
ConclusionOur study provides further insight into factors potentially associated with erythropoiesis in pediatric kidney transplant recipients.Graphical abstractA higher resolution version of the Graphical abstract is available as Supplementary information
Conclusion: Molidustat was noninferior to darbepoetin and maintained Hb levels in the prespecified target range in patients with renal anemia not undergoing dialysis and previously treated with ESA. Molidustat was well tolerated, and no new safety signal was observed.Am J Nephrol
Conclusion: In the MIYABI ND-C study, molidustat appeared to be an efficacious and generally well-tolerated alternative to darbepoetin for the treatment of renal anemia in Japanese patients who were not undergoing dialysis and were not receiving ESA treatment.Am J Nephrol
Anemia is a common complication of chronic kidney disease, affecting the quality of life of patients. Among various factors, such as iron and erythropoietin deficiency, reduced red blood cell (RBC) lifespan has been implicated in the pathogenesis of anemia. However, mechanistic data on in vivo RBC dysfunction in kidney disease are lacking. Herein, we describe the development of chronic kidney disease-associated anemia in mice with proteinuric kidney disease resulting from either administration of doxorubicin or an inducible podocin deficiency.
Ann Cardiol Angeiol (Paris). 2021 Sep 10:S0003-3928(21)00087-1. doi: 10.1016/j.ancard.2021.07.004. Online ahead of print.ABSTRACTBACKGROUND: The increasing prevalence and poor prognosis associated with chronic heart failure (CHF) have made the improvement of quality of life (QoL) one of the main goals in the treatment of CHF patients. Since little is known about the QoL in Tunisian patients with heart failure (HF), the current study was performed to assess QoL in a sample of Tunisian patients hospitalized with HF and to identify factors related to QoL.METHODS: In this prospective study, we evaluated patients with CHF atten...
ConclusionRoxadustat improved hemoglobin similarly to ESA while demonstrating comparable cardiovascular and overall safety profiles in a wide spectrum of dialysis-dependent patients with anemia of CKD. Roxadustat represents an oral alternative to ESAs for achieving a target hemoglobin for anemia of CKD in dialysis-dependent patients.
This study investigated drug-drug interactions between vadadustat and oral iron supplements or iron-containing phosphate binders commonly used in Japanese clinical practice by conducting in vitro mechanistic and clinical pharmacokinetic studies.METHODS: In the in vitro assessment, chelate formation of vadadustat with iron-containing agents was investigated in water and in a fed-state simulated intestinal fluid. Chelate formation was assessed by observation of a chelate-specific color, and the concentration of vadadustat was determined. In the single-dose, open-label, randomized, crossover clinical study, healthy male parti...
Discussion Kidneys are amazing in that they filter the blood, eliminate toxins, balance fluids and electrolytes plus have a lot of reserve to do the job they need to do even when injured. Therefore, depending on the problem, chronic renal disease (CRD) often allows time before renal replacement therapy (RRT) is needed. RRT currently is dialysis (peritoneal or hemodialysis) or renal transplant. In general, the patient’s own kidneys do the best job for them but there is always a balance between the problems of CRD and its management, versus the potentially improved renal function with RRT. RRT itself though has a diffe...