Project Title: |
CALCI-CINA : Study on the Use of Cinacalcet in Phosphocalcic Context |
Project Type: |
Observational Study, Enrolment ongoing |
Disease group(s): |
Pediatric CKD & dialysis |
Project Summary: |
Currently, indications retained for the marketing authorization for cinacalcet (calcimimetic) in Europe are hyperparathyroidism in adults, whether primary (for patients in whom parathyroidectomy would in theory be indicated but in whom it is contraindicated or not is not clinically appropriate) or secondary to CKD, and parathyroid carcinoma. In pediatrics, data on its use are limited due to its recent Marketing Authorization (2017) and limited to dialysis patients with secondary hyperPTH. Nevertheless, some patients with phosphocalcic pathologies without renal insufficiency must be treated outside Marketing Authorization with cinacalcet in the face of severe hyperPTH, without any other chronic treatment available to date. The objective of this study is therefore to evaluate the use in France of cinacalcet in phosphocalcic pathologies without renal failure, in order to obtain efficacy and safety data in order to improve our knowledge on the management of these orphan diseases. |
Lead principal investigator(s): |
Justine Bacchetta, Lyon |
Co-investigator(s): |
Igor Tauveron, Clermont-Ferrand Rober Novo, Lille Anne Lienhardt-Roussie, Limoges Emam Allain-Launay, Nantes Laetitia Martinerie, Paris Pierre-François Souchon, Reims Nathalie Jeandidier, Strasbourg Lise Criniere, Tours |
Project Period: |
01/2020 - 12/2023 |