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Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis.
Pediatr Nephrol. 2020 09; 35(9):1679-1697.PN

Abstract

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.

Authors+Show Affiliations

Division of Pediatric Nephrology, Children's Mercy Kansas City, Kansas City, MO, USA. bwarady@cmh.edu.Amgen Inc., Thousand Oaks, CA, USA.Amgen Inc., Thousand Oaks, CA, USA.Amgen Inc., Thousand Oaks, CA, USA.Heidelberg University Hospital, Heidelberg, Germany.Department of Pediatric Nephrology, Rheumatology and Dermatology, Femme Mère Enfant Hospital, Bron, France.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

32367309

Citation

Warady, Bradley A., et al. "Cinacalcet Studies in Pediatric Subjects With Secondary Hyperparathyroidism Receiving Dialysis." Pediatric Nephrology (Berlin, Germany), vol. 35, no. 9, 2020, pp. 1679-1697.
Warady BA, Ng E, Bloss L, et al. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020;35(9):1679-1697.
Warady, B. A., Ng, E., Bloss, L., Mo, M., Schaefer, F., & Bacchetta, J. (2020). Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatric Nephrology (Berlin, Germany), 35(9), 1679-1697. https://doi.org/10.1007/s00467-020-04516-4
Warady BA, et al. Cinacalcet Studies in Pediatric Subjects With Secondary Hyperparathyroidism Receiving Dialysis. Pediatr Nephrol. 2020;35(9):1679-1697. PubMed PMID: 32367309.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. AU - Warady,Bradley A, AU - Ng,Eric, AU - Bloss,Laura, AU - Mo,May, AU - Schaefer,Franz, AU - Bacchetta,Justine, Y1 - 2020/05/04/ PY - 2019/08/14/received PY - 2020/02/21/accepted PY - 2020/02/18/revised PY - 2020/5/6/pubmed PY - 2021/6/16/medline PY - 2020/5/6/entrez KW - CKD-MBD KW - Cinacalcet KW - Dialysis KW - Pediatric KW - sHPT SP - 1679 EP - 1697 JF - Pediatric nephrology (Berlin, Germany) JO - Pediatr Nephrol VL - 35 IS - 9 N2 - 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. SN - 1432-198X UR - https://wwww.unboundmedicine.com/medline/citation/32367309/Cinacalcet_studies_in_pediatric_subjects_with_secondary_hyperparathyroidism_receiving_dialysis_ DB - PRIME DP - Unbound Medicine ER -