Study on the Use of Cinacalcet in Phosphocalcic Context.
NCT ID: NCT04126954
Last Updated: 2019-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
25 participants
OBSERVATIONAL
2020-01-31
2023-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cinacalcet
Patients with primary or secondary hyperPTH resulting from phosphocalcic pathology treated by cinacalcet
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
99 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Justine BACCHETTA, MD
Role: PRINCIPAL_INVESTIGATOR
Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques
Locations
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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, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019_CALCI-CINA
Identifier Type: -
Identifier Source: org_study_id
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