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Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis
Bradley A Warady1, Eric Ng2, Laura Bloss2
1Division of Pediatric Nephrology, Children's Mercy Kansas City, Kansas City, MO, USA. bwarady@cmh.edu.
Insights
Cinacalcet shows varied but significant efficacy in reducing parathyroid hormone (PTH) in pediatric patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT). This review offers comprehensive data on its use in children.
Area of Science:
- Pediatric Nephrology
- Endocrinology
- Pharmacology
Background:
- Secondary hyperparathyroidism (sHPT) is a common complication in children with chronic kidney disease (CKD), affecting 50% of those on dialysis.
- sHPT contributes to CKD-mineral and bone disorder (CKD-MBD), increasing risks of fractures and vascular calcification.
- Current pediatric sHPT treatment relies on vitamin D sterols, calcium, and phosphate binders, with limited options for calcimimetics.
Purpose of the Study:
- To review the safety and efficacy of cinacalcet for treating secondary hyperparathyroidism (sHPT) in pediatric patients with chronic kidney disease (CKD).
- To consolidate data from Amgen-sponsored and independent clinical studies on cinacalcet's pediatric use.
- To provide dosing information to inform the pediatric nephrology community.
Main Methods:
- Review of data from two Phase 3 randomized studies, one Phase 3 extension study, one Phase 2 study, and two Phase 1 studies sponsored by Amgen.
- Inclusion of data from non-Amgen supported clinical studies evaluating cinacalcet in pediatric CKD patients.
- Analysis of cinacalcet's effects on parathyroid hormone (PTH) levels and achievement of target ranges.
Main Results:
- Cinacalcet demonstrated varied effects on PTH levels across studies, with 7.4% to 57.1% of subjects achieving target PTH ranges.
- A significant reduction (≥ 30%) in PTH was observed in 22.2% to 70.6% of pediatric patients.
- Independent clinical studies also confirmed significant reductions in PTH levels with cinacalcet use.
Conclusions:
- This manuscript provides the most comprehensive review to date on cinacalcet usage in pediatric CKD patients.
- The data suggest cinacalcet can be effective in managing sHPT in children with CKD.
- Further information on dosing, safety, and efficacy supports its consideration in pediatric nephrology practice.
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.
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