Compassionate use of roxadustat for treatment of refractory renal anemia in an infant.

Anemia Chronic kidney disease Erythropoiesis-stimulating agent Hypoxia-inducible factor prolyl hydroxylase inhibitor Infant Roxadustat

Journal

Pediatric nephrology (Berlin, Germany)
ISSN: 1432-198X
Titre abrégé: Pediatr Nephrol
Pays: Germany
ID NLM: 8708728

Informations de publication

Date de publication:
13 Dec 2023
Historique:
received: 31 05 2023
accepted: 20 11 2023
revised: 18 11 2023
medline: 13 12 2023
pubmed: 13 12 2023
entrez: 12 12 2023
Statut: aheadofprint

Résumé

Erythropoiesis-stimulating agents (ESAs) have played an important role in the treatment of renal anemia in children, but cannot improve hemoglobin to target level in some cases. Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, can stimulate endogenous erythropoietin production and regulate iron metabolism even in patients with kidney failure. However, roxadustat has not yet been approved for use in children. We report a case of refractory renal anemia in an 80-day-old boy, who was hyporesponsive to ESAs even in combination with iron supplementation and transfusion. Compassionate use of roxadustat successfully corrected the intractable anemia. Hyperkalemia is a manageable adverse event of concern during follow-up. The successful experience in this case may inform the clinical utility of roxadustat for refractory renal anemia in children, which should be further confirmed by well-designed prospective clinical trials.

Sections du résumé

BACKGROUND BACKGROUND
Erythropoiesis-stimulating agents (ESAs) have played an important role in the treatment of renal anemia in children, but cannot improve hemoglobin to target level in some cases. Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, can stimulate endogenous erythropoietin production and regulate iron metabolism even in patients with kidney failure. However, roxadustat has not yet been approved for use in children.
CASE-DIAGNOSIS/TREATMENT METHODS
We report a case of refractory renal anemia in an 80-day-old boy, who was hyporesponsive to ESAs even in combination with iron supplementation and transfusion. Compassionate use of roxadustat successfully corrected the intractable anemia. Hyperkalemia is a manageable adverse event of concern during follow-up.
CONCLUSION CONCLUSIONS
The successful experience in this case may inform the clinical utility of roxadustat for refractory renal anemia in children, which should be further confirmed by well-designed prospective clinical trials.

Identifiants

pubmed: 38086983
doi: 10.1007/s00467-023-06240-1
pii: 10.1007/s00467-023-06240-1
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2023. The Author(s).

Références

Sinai-Trieman L, Salusky IB, Fine RN (1989) Use of subcutaneous recombinant human erythropoietin in children undergoing continuous cycling peritoneal dialysis. J Pediatr 114(4 Pt 1):550–554. https://doi.org/10.1016/s0022-3476(89)80692-4
doi: 10.1016/s0022-3476(89)80692-4 pubmed: 2926567
Weir MR (2021) Managing anemia across the stages of kidney disease in those hyporesponsive to erythropoiesis-stimulating agents. Am J Nephrol 52:450–466. https://doi.org/10.1159/000516901
doi: 10.1159/000516901 pubmed: 34280923
Dhillon S (2019) Roxadustat: first global approval. Drugs 79:563–572. https://doi.org/10.1007/s40265-019-01077-1
doi: 10.1007/s40265-019-01077-1 pubmed: 30805897
Li ZL, Tu Y, Liu BC (2020) Treatment of renal anemia with roxadustat: advantages and achievement. Kidney Dis (Basel) 6:65–73. https://doi.org/10.1159/000504850
doi: 10.1159/000504850 pubmed: 32309288
Hoshino J, Muenz D, Zee J, Sukul N, Speyer E, Guedes M, Lopes AA, Asahi K, van Haalen H, James G, Dhalwani N, Pecoits-Filho R, Bieber B, Robinson BM, Pisoni RL, CKDopps Investigators, (2020) Associations of hemoglobin levels with health-related quality of life, physical activity, and clinical outcomes in persons with stage 3–5 nondialysis CKD. J Ren Nutr 30:404–414. https://doi.org/10.1053/j.jrn.2019.11.003
doi: 10.1053/j.jrn.2019.11.003 pubmed: 31980326
Thorp ML, Johnson ES, Yang X, Petrik AF, Platt R, Smith DH (2009) Effect of anaemia on mortality, cardiovascular hospitalizations and end-stage renal disease among patients with chronic kidney disease. Nephrology (Carlton) 14:240–246. https://doi.org/10.1111/j.1440-1797.2008.01065.x
doi: 10.1111/j.1440-1797.2008.01065.x pubmed: 19207866
Atkinson MA, Martz K, Warady BA, Neu AM (2010) Risk for anemia in pediatric chronic kidney disease patients: a report of NAPRTCS. Pediatr Nephrol 25:1699–1706. https://doi.org/10.1007/s00467-010-1538-6
doi: 10.1007/s00467-010-1538-6 pubmed: 20464428
van Stralen KJ, Krischock L, Schaefer F, Verrina E, Groothoff JW, Evans J, Heaf J, Ivanov D, Kostic M, Maringhini S, Podracká L, Printza N, Pundziene B, Reusz GS, Vondrak K, Jager KJ, Tizard EJ, ESPN, ERA-EDTA Registry, (2012) Prevalence and predictors of the sub-target Hb level in children on dialysis. Nephrol Dial Transplant 27:3950–3957. https://doi.org/10.1093/ndt/gfs178
doi: 10.1093/ndt/gfs178 pubmed: 22740719
Durkan AM, Keating LE, Vigneux A, Geary DF (2006) The use of darbepoetin in infants with chronic renal impairment. Pediatr Nephrol 21:694–697. https://doi.org/10.1007/s00467-006-0067-9
doi: 10.1007/s00467-006-0067-9 pubmed: 16565871
Libudzic-Nowak AM, Cachat F, Pascual M, Chehade H (2018) Darbepoetin alfa in young infants with renal failure: single center experience, a case series and review of the literature. Front Pediatr 6:398. https://doi.org/10.3389/fped.2018.00398
doi: 10.3389/fped.2018.00398 pubmed: 30619793 pmcid: 6305342
Wu M, Zang C, Ma F, Chen B, Liu J, Xu Z (2022) Hypoxia-inducible factor prolyl hydroxylase inhibitors for anaemia in maintenance dialysis: a meta-analysis. Clin Exp Nephrol 26:1043–1054. https://doi.org/10.1007/s10157-022-02263-4
doi: 10.1007/s10157-022-02263-4 pubmed: 36006596
Hashiguchi J, Funakoshi S, Sawase K, Kawazu T, Hayashi K, Yamaguchi K (2020) Effects of roxadustat treatment on serum parathyroid hormone (PTH) in hemodialysis patients with erythropoiesis-stimulating agent (ESA) resistant anemia [PO0266]. J Am Soc Nephrol 31:133–134
National Library of Medicine (2021) Investigating the efficacy and safety of roxadustat (FG-4592) for treatment of anemia in pediatric patients with CKD. https://www.clinicaltrials.gov/study/NCT04925011 . Accessed 20 May 2023
Chen N, Hao C, Liu BC, Lin H, Wang C, Xing C, Liang X, Jiang G, Liu Z, Li X, Zuo L, Luo L, Wang J, Zhao MH, Liu Z, Cai GY, Hao L, Leong R, Wang C, Liu C, Neff T, Szczech L, Yu KP (2019) Roxadustat Treatment for Anemia in Patients Undergoing Long-Term Dialysis. N Engl J Med 381:1011–1022. https://doi.org/10.1056/NEJMoa1901713
doi: 10.1056/NEJMoa1901713 pubmed: 31340116
Liu J, Zhang A, Hayden JC, Bhagavathula AS, Alshehhi F, Rinaldi G, Kontogiannis V, Rahmani J (2020) Roxadustat (FG-4592) treatment for anemia in dialysis-dependent (DD) and not dialysis-dependent (NDD) chronic kidney disease patients: a systematic review and meta-analysis. Pharmacol Res 155:104747. https://doi.org/10.1016/j.phrs.2020.104747
doi: 10.1016/j.phrs.2020.104747 pubmed: 32171893

Auteurs

Yan Yang (Y)

Department of Pediatrics, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.
Pediatric Key Laboratory of Xiamen, Xiamen, Fujian, China.
Institute of Pediatrics, School of Medicine, Xiamen University, Xiamen, Fujian, China.

Yan Chen (Y)

Department of Pediatrics, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.
Pediatric Key Laboratory of Xiamen, Xiamen, Fujian, China.
Institute of Pediatrics, School of Medicine, Xiamen University, Xiamen, Fujian, China.

Yang Yang (Y)

Department of Pediatrics, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.
Pediatric Key Laboratory of Xiamen, Xiamen, Fujian, China.
Institute of Pediatrics, School of Medicine, Xiamen University, Xiamen, Fujian, China.

Haitao Bai (H)

Department of Pediatrics, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China. baihaitao@163.com.
Pediatric Key Laboratory of Xiamen, Xiamen, Fujian, China. baihaitao@163.com.
Institute of Pediatrics, School of Medicine, Xiamen University, Xiamen, Fujian, China. baihaitao@163.com.

Bizi He (B)

Department of Pediatrics, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.
Pediatric Key Laboratory of Xiamen, Xiamen, Fujian, China.
Institute of Pediatrics, School of Medicine, Xiamen University, Xiamen, Fujian, China.

Dengli Liu (D)

Department of Pediatrics, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.
Pediatric Key Laboratory of Xiamen, Xiamen, Fujian, China.
Institute of Pediatrics, School of Medicine, Xiamen University, Xiamen, Fujian, China.

Classifications MeSH