Efficacy and Safety of Daprodustat for Treatment of Anemia of Chronic Kidney Disease in Incident Dialysis Patients

Abstract

Key Points Question Is daprodustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, an effective oral alternative to darbepoetin alfa in the treatment of anemia of chronic kidney disease (CKD) in incident dialysis (ID) patients? Findings In this randomized clinical trial of 312 ID patients, daprodustat was noninferior to darbepoetin alfa in treating anemia of CKD; the difference in mean hemoglobin concentration between study arms during the evaluation period was 10.5 g/dL for patients receiving daprodustat and 10.6 g/dL for patients receiving darbepoetin alfa. Meaning The study results suggest that daprodustat represents an oral alternative treatment to a conventional erythropoiesis-stimulating agent in the ID population.

The prebiotic effects of soluble dietary fiber mixture on renal anemia and the gut microbiota in end-stage renal disease patients on maintenance hemodialysis: a prospective, randomized, placebo-controlled study

“…However, an increasing number of patients also present clinically with EPO hyporesponse, which may be related to factors such as iron metabolism disorder and EPO receptor dysfunction. Recently, with the application of hypoxia inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in the clinic, the standard rate of treatment of renal anemia in ESRD dialysis patients has been further improved [ 23 , 24 ]. However, renal anemia is a multifactorial disease, and the diversity of its etiologies has contributed to its need for multitarget therapies.…”

Supplementum 266: Abstracts of the 54th Annual Meeting of the Swiss Society of Nephrology

“…In this post hoc exploratory analysis, cardiovascular safety results from eligible patients with anemia of CKD enrolled in four phase 3,randomized,openlabel studies (NDD [DOLOMITES] or ID-DD [SIERRAS, HIMALAYAS, ROCKIES]) were pooled and compared between roxadustat and an ESA. Time to major adverse cardiovascular event (MACE), MACE+ (MACE plus congestive heart failure or unstable angina requiring hospitalization), and all-cause mortality (ACM) was evaluated in subgroups established from baseline characteristics.…”

“…were considered having a systemic disease. The remaining 393 SF (321 calcium, 63 uric acid, 9 infection) were screened for full MS/features thereof (definition IDF [2]), LDL-cholesterol (LDL-C) >3.0 mmol/l ( risk for coronary death [3]), urine volume <1.2 L/d likely caused by reduced thirst sensitivity/AVP dysregulation [4], and low bone mass.…”

“…An easy-to-perform assay to detect HLA-specific memory B cells: A missing tool in the HLA lab * Dr. Caroline Wehmeier 1 , Mrs. Aynur Gubelmann 2 , Mr. Marc Kleiser 2 , Mrs. Claudia Petit 2 , Mrs. Amanda Puglia 2 , Mrs. Dominique Roubaty 2 , Dr. Patrizia Amico 1 , Prof. Stefan Schaub 1 , Dr. Gideon Hönger 3 1. Clinic for Transplantation Immunology and Nephrology, University Hospital Basel, Basel, Switzerland 2.…”

Hypoxia-inducible factor prolyl hydroxylase enzyme inhibitors: ready for primetime?

“…In the daprodustat program, there were no differences in IV iron utilization between the HIF-PH inhibitor and comparator ESA groups apart from a subgroup of hyporesponders in the DD study who required slightly less IV iron [8 ▪▪ ,9 ▪▪ ]. In the Japanese phase 3 program, 32% of patients receiving daprodustat required intravenous iron during the treatment period compared to 43% with darbepoetin [21], and in a study of incident dialysis patients, daprodustat was not superior compared to darbepoetin alfa in reducing monthly IV iron use (adjusted mean treatment difference, 19.4 mg [95% CI: –11.0 to 49.9 mg]), with a reduction in mean monthly IV iron use from baseline to week 52 in both treatment groups [22]. No data are reported for iron utilization in the vadadustat program [6 ▪▪ ,7 ▪▪ ].…”