Study on the Use of Cinacalcet in Phosphocalcic Context.
CALCI-CINA
Multicentric Retrospective Study on the Use of Cinacalcet in an Off-label Phosphocalcic Context
1 other identifier
observational
25
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2020
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedOctober 15, 2019
October 1, 2019
1 year
October 11, 2019
October 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum PTH concentration
3 months after treatment initiation
Secondary Outcomes (4)
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
Study Arms (1)
Cinacalcet
Patients with primary or secondary hyperPTH resulting from phosphocalcic pathology treated by cinacalcet
Interventions
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
Patients with phosphocalcic diseases suffering from hyperPTH without end-stage renal failure.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Endocrinologie Diabète et Maladies Métaboliques - Hôpital Gabriel Montpied
Clermont-Ferrand, France
Service de Néphrologie Pédiatrique -Hôpital Jeanne de Flandre
Lille, 59037, France
Service d'Endocrinologie Pédiatrique - Hôpital de la mère et de l'Enfant
Limoges, 87042, France
Pole Femme Mère Enfant - Pédiatrie spécialisée - Centre Hospitalier Universitaire
Montpellier, 34090, France
Service de Néphrologie pédiatrique - Clinique Médicale Pédiatrique
Nantes, 44093, France
Service d'endocrinologie et Diabétologie Pédiatrique-Hôpital Robert Debré
Paris, 75019, France
Service de Diabétologie et endocrinologie pédiatriques - Centre Hospitalier Universitaire
Reims, 51100, France
Pôle Néphrologie-Urologie-Diabétologie-Endocrinologie
Strasbourg, 67091, France
Service d'Endocrinologie, Maladies Osseuses, Gynécologie, Génétique
Toulouse, 31059, France
Unité Endocrinologie, Nutrition, Diabétologie -Hôpital Bretonneau
Tours, 37044, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justine BACCHETTA, MD
Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2019
First Posted
October 15, 2019
Study Start
January 1, 2020
Primary Completion
January 1, 2021
Study Completion
December 1, 2023
Last Updated
October 15, 2019
Record last verified: 2019-10