Affiliation:
1. People's Hospital of Jintan District,Changzhou City
2. National Clinical Research Center of Kidney Diseases, Nanjing University
3. Affiliated Hospital of Xuzhou Medical University
Abstract
Abstract
Background
Roxadustat is an oral hypoxy inducing factor-prolyl hydroxylase inhibitor (HIF-PHI) that regulates iron metabolism in patients with chronic kidney disease (CKD) primarily by reducing hepcidin levels and mobilizing internal iron stores. More data are needed to demonstrate the efficacy of roxadustat in regulating iron metabolism in patients with peritoneal dialysis (PD) compared with erythropoiesis stimulating agents (ESAs).
Methods
This prospective cohort study enrolled PD patients with a mean hemoglobin level of 60 to 100 g/L. All subjects were randomized into two groups at a ratio of 2:1: the roxadustat group (106 cases), and the ESA group (53 cases). The primary endpoint was the change in the iron biomarker levels and the proportion of patients with absolute iron deficiency and functional iron deficiency.
Results
Compared with ESAs, roxadustat significantly decreased hepcidin level (difference,-20.09ng/mL; 95% CI, -30.26 to -9.92), attenuated the increase in serum soluble transferrin receptor (sTFR) level (difference, -7.87 nmol/L; 95% CI, -12.11 to -3.64), and reduced the proportion of patients with functional iron deficiency (roxadustat, 11.43%; ESA, 33.33%). There was no significant difference in safety of the two groups over the duration of the study.
Conclusions
Compared with ESA group, roxadustat group showed significant difffferences in all iron biomarker levels except serum ferritin (sFt) and transferrin saturation (TSAT). These results suggest that roxadustat was superior to ESAs as a therapy for iron metabolism in PD patients.
Trial registration:
This study completed Chinese Clinical Trial Registration on March 4,2022 (registration number: ChiCTR2200057231).
Publisher
Research Square Platform LLC
Reference42 articles.
1. Shaikh H, Hashmi MF, Aeddula NR. Anemia of chronic renal disease. In: StatPearls. StatPearls Publishing, Treasure Island (FL): 2022
2. Update on anemia in ESRD and earlier stages of CKD: core curriculum 2018;Fishbane S;Am J Kidney Dis,2018
3. Iron deficiency;Pasricha SR;Lancet,2021
4. Hepcidin and iron in health and disease;Nemeth E;Annu Rev Med,2022
5. Prolyl hydroxylase inhibitors: a new opportunity in renal and myocardial protection;Requena-Ibáñez JA;Cardiovasc Drugs Ther,2022