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Study on the Use of Cinacalcet in Phosphocalcic Context. — CALCI-CINA  

Hyperparathyroidism, Secondary Clinical Trial

Official title:
Multicentric Retrospective Study on the Use of Cinacalcet in an Off-label Phosphocalcic Context

Clinical Trial Summary

Currently, the indications used for MA (Marketing Authorization) Cinacalcet in France are hyperparathyroidism (hyperPTH) in adults, whether primary (for patients in whom parathyroidectomy is theoretically indicated but in whom it is contraindicated or not is not clinically appropriate) or secondary to a chronic kidney disease, and parathyroid carcinomas.

In pediatric patients, data on its use are restricted due to its recent marketing authorization (2017) and limited to dialysis patients suffering from secondary hyperPTH.

Nevertheless, some patients with phosphocalcic pathologies without renal insufficiency must be treated off-label by cinacalcet in the presence 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 insufficiency, in order to obtain efficacy and safety data in order to improve our knowledge on the management of these orphan diseases.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04126954
Study type Observational
Source Hospices Civils de Lyon
Contact Justine BACCHETTA, MD
Phone 4 27 85 61 30
Email justine.bacchetta@chu-lyon.fr
Status Not yet recruiting
Phase
Start date January 2020
Completion date December 2023
View Details
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