Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis.
Background: Secondary hyperparathyroidism (sHPT), a complication of chronic kidney disease (CKD) characterized by persistently elevated parathyroid hormone (PTH), alterations in calcium-phosphorus homeostasis, and vitamin D metabolism, affects 50% of children receiving dialysis. A significant propor...
| Publicado en: | Pediatric Nephrology Vol. 35; no. 9; pp. 1679 - 1698 |
|---|---|
| Autores principales: | , , , , , |
| Formato: | review tables/charts Journal Article |
| Publicado: |
Springer Nature
Sep2020
|
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=144783744&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 144783744 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 0931041X EF1 jtl: Pediatric Nephrology issn: 0931041X maglogo: N pubinfo: dt: Sep2020 vid: 35 iid: 9 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 144783744 144161976 144783744 144783744 10.1007/s00467-020-04516-4 144783744 ppf: 1679 ppct: 19 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. aug: au: Warady, Bradley A. Ng, Eric Bloss, Laura Mo, May Schaefer, Franz Bacchetta, Justine affil: Division of Pediatric Nephrology, Children's Mercy Kansas City, Kansas City, MO, USA sug: subj: Hormone Antagonists Administration and Dosage Hyperparathyroidism Drug Therapy Dialysis Patients In Infancy and Childhood Child Hormone Antagonists Therapeutic Use Hormone Antagonists Pharmacodynamics Parathyroid Hormones Drug Effects Kidney Failure, Chronic Complications Bone Diseases Risk Factors Minerals Metabolism Risk Assessment Child: 6-12 years ab: Background: Secondary hyperparathyroidism (sHPT), a complication of chronic kidney disease (CKD) characterized by persistently elevated parathyroid hormone (PTH), alterations in calcium-phosphorus homeostasis, and vitamin D metabolism, affects 50% of children receiving dialysis. A significant proportion of these children develop CKD-mineral and bone disorder (CKD-MBD), associated with an increased risk of fractures and vascular calcification. The standard of care for sHPT in children includes vitamin D sterols, calcium supplementation, and phosphate binders. Several agents are approved for sHPT treatment in adults undergoing dialysis, including vitamin D analogs and calcimimetics, with limited information on their safety and efficacy in children. The calcimimetic cinacalcet is approved for use in adults with sHPT on dialysis, but is not approved for pediatric use outside Europe. Methods: This review provides dosing, safety, and efficacy information from Amgen-sponsored cinacalcet pediatric trials and data from non-Amgen sponsored clinical studies. Results: The Amgen cinacalcet pediatric clinical development program consisted of two Phase 3 randomized studies, one Phase 3 single arm extension study, one open-label Phase 2 study, and two open-label Phase 1 studies. Effects of cinacalcet on PTH varied across studies. Overall, 7.4 to 57.1% of subjects who received cinacalcet in an Amgen clinical trial attained PTH levels within recommended target ranges and 22.2 to 70.6% observed a ≥ 30% reduction in PTH. In addition, significant reductions in PTH were demonstrated in all non-Amgen-supported studies. Conclusions: To help inform the pediatric nephrology community, this manuscript contains the most comprehensive review of cinacalcet usage in pediatric CKD patients to date. pubtype: Academic Journal doctype: review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|