Study on the Use of Cinacalcet in Phosphocalcic Context.

Hyperparathyroidism, Secondary Clinical Trial

— CALCI-CINA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04126954
• Other study ID #: 2019_CALCI-CINA
• Status: Not yet recruiting
• Start date: January 2020
• Est. completion date: December 2023

Study information

• Verified date: October 2019
• Source: Hospices Civils de Lyon
• Contact: Justine BACCHETTA, MD
• Phone: 4 27 85 61 30
• Email: justine.bacchetta[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 2023
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 99 Years

Eligibility

Inclusion Criteria:

• Patients with phosphocalcic pathology without end-stage renal failure

• Patients followed in one of the hospitals of the centers of reference and competence of the diseases of the metabolism of calcium and phosphate

• For children under 18: patient and parent (s) / parent having been informed of the study and having expressed their on-opposition

• For adults: patient / legal guardian of the patient under guardianship having been informed of the study and expressing his or her non opposition

Exclusion Criteria:

• Patient suffering from parathyroid cancer,

• Patient suffering from primary hyperPTH in whom parathyroidectomy would theoretically be indicated but contraindicated or clinically inappropriate,

• Patient suffering from hyperPTH secondary to end-stage renal failure

• No social security support

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Hyperparathyroidism, Secondary

Intervention

Other:
• Serum PTH concentrations results
To compare serum PTH concentrations results in patients with primary or secondary hyperPTH resulting from phosphocalcic pathology before and three months after initiation of cinacalcet therapy.

Locations

Country	Name	City	State
France	Endocrinologie Diabète et Maladies Métaboliques - Hôpital Gabriel Montpied	Clermont-Ferrand
France	Service de Néphrologie Pédiatrique -Hôpital Jeanne de Flandre	Lille
France	Service d'Endocrinologie Pédiatrique - Hôpital de la mère et de l'Enfant	Limoges
France	Pole Femme Mère Enfant - Pédiatrie spécialisée - Centre Hospitalier Universitaire	Montpellier
France	Service de Néphrologie pédiatrique - Clinique Médicale Pédiatrique	Nantes
France	Service d'endocrinologie et Diabétologie Pédiatrique-Hôpital Robert Debré	Paris
France	Service de Diabétologie et endocrinologie pédiatriques - Centre Hospitalier Universitaire	Reims
France	Pôle Néphrologie-Urologie-Diabétologie-Endocrinologie	Strasbourg
France	Service d'Endocrinologie, Maladies Osseuses, Gynécologie, Génétique	Toulouse
France	Unité Endocrinologie, Nutrition, Diabétologie -Hôpital Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum PTH concentration		3 months after treatment initiation
Secondary	Serum PTH concentration		1 month after treatment initiation
Secondary	Serum PTH concentration		6 months after treatment initiation
Secondary	Serum PTH concentration		12 months after treatment initiation
Secondary	Serum PTH concentration		3 years after treatment initiation