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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04126954

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

2.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hyperparathyroidism, Secondary Hyperparathyroidism, Primary	Other: Serum PTH concentrations results

Study Design

Study Type:

Observational

Anticipated Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cinacalcet Patients with primary or secondary hyperPTH resulting from phosphocalcic pathology treated by cinacalcet	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.

Arm

Intervention/Treatment

Cinacalcet

Patients with primary or secondary hyperPTH resulting from phosphocalcic pathology treated by cinacalcet

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.

Outcome Measures

Primary Outcome Measures

Serum PTH concentration [3 months after treatment initiation]

Secondary Outcome Measures

Serum PTH concentration [1 month after treatment initiation]
Serum PTH concentration [6 months after treatment initiation]
Serum PTH concentration [12 months after treatment initiation]
Serum PTH concentration [3 years after treatment initiation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Endocrinologie Diabète et Maladies Métaboliques - Hôpital Gabriel Montpied	Clermont-Ferrand	France
2	Service de Néphrologie Pédiatrique -Hôpital Jeanne de Flandre	Lille	France	59037
3	Service d'Endocrinologie Pédiatrique - Hôpital de la mère et de l'Enfant	Limoges	France	87042
4	Pole Femme Mère Enfant - Pédiatrie spécialisée - Centre Hospitalier Universitaire	Montpellier	France	34090
5	Service de Néphrologie pédiatrique - Clinique Médicale Pédiatrique	Nantes	France	44093
6	Service d'endocrinologie et Diabétologie Pédiatrique-Hôpital Robert Debré	Paris	France	75019
7	Service de Diabétologie et endocrinologie pédiatriques - Centre Hospitalier Universitaire	Reims	France	51100
8	Pôle Néphrologie-Urologie-Diabétologie-Endocrinologie	Strasbourg	France	67091
9	Service d'Endocrinologie, Maladies Osseuses, Gynécologie, Génétique	Toulouse	France	31059
10	Unité Endocrinologie, Nutrition, Diabétologie -Hôpital Bretonneau	Tours	France	37044

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: Justine BACCHETTA, MD, Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT04126954

Other Study ID Numbers:

2019_CALCI-CINA

First Posted:

Oct 15, 2019

Last Update Posted:

Oct 15, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

Hyperparathyroidism

pathology phosphocalcic

Additional relevant MeSH terms:

Hyperparathyroidism

Hyperparathyroidism, Secondary

Hyperparathyroidism, Primary

Study Results

No Results Posted as of Oct 15, 2019