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Study on the Use of Cinacalcet in Phosphocalcic Context.

NCT04126954 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2019-10-15

No results posted yet for this study

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.

Conditions

  • Hyperparathyroidism, Secondary
  • Hyperparathyroidism, Primary

Interventions

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Justine BACCHETTA, MD · Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques

Eligibility

Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-01-31
Completion
2023-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04126954 on ClinicalTrials.gov