Hyperparathyroidism, SecondaryCALCI-CINANCT04126954
Study on the Use of Cinacalcet in Phosphocalcic Context.
An observational study of Hyperparathyroidism, Secondary and Hyperparathyroidism, Primary, run by Hospices Civils de Lyon at 10 sites in France.
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… Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Hyperparathyroidism, Secondary, Hyperparathyroidism, Primary
- What is being tested?
- Serum PTH concentrations results
- How many people
- 25 participants
- Where
- 10 sitesFrance
- Study dates
- Jan 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with phosphocalcic diseases suffering from hyperPTH without end-stage renal failure.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Endocrinologie Diabète et Maladies Métaboliques - Hôpital Gabriel Montpied
Clermont-Ferrand
Igor TAUVERON, PR, 4 73 75 15 33 ext. +33, itauveron@chu-clermontferrand.fr
Service de Néphrologie Pédiatrique -Hôpital Jeanne de Flandre
Lille, 59037
Robert NOVO, MD, 03.20.44.46.95 ext. +33, robert.novo@chru-lille.fr
Service d'Endocrinologie Pédiatrique - Hôpital de la mère et de l'Enfant
Limoges, 87042
Anne LIENHARDT-ROUSSIE, MD, 5.55.05.63.58 ext. +33, anne.lienhardt@chu-limoges.fr
Pole Femme Mère Enfant - Pédiatrie spécialisée - Centre Hospitalier Universitaire
Montpellier, 34090
Cyril AMOUROUX, MD, 4 67 33 81 12 ext. +33, cyril-amouroux@chu-montpellier.fr
Service de Néphrologie pédiatrique - Clinique Médicale Pédiatrique
Nantes, 44093
Emma ALLAIN-LAUNAY, MD, 240083660 ext. +33, emma.allainlaunay@chu-nantes.fr
Service d'endocrinologie et Diabétologie Pédiatrique-Hôpital Robert Debré
Paris, 75019
Laeticia MARTINERIE, MD, 1.40.03.53.03 ext. +33, laetitia.martinerie@aphp.fr
Service de Diabétologie et endocrinologie pédiatriques - Centre Hospitalier Universitaire
Reims, 51100
Pierre-François SOUCHON, MD, pfsouchon@chu-reims.fr
Pôle Néphrologie-Urologie-Diabétologie-Endocrinologie
Strasbourg, 67091
Nathalie JEANDIDIER, PR, 3 88 11 66 03 ext. +33, nathalie.jeandidier@chru-strasbourg.fr
Service d'Endocrinologie, Maladies Osseuses, Gynécologie, Génétique
Toulouse, 31059
Jean Pierre SALLES, MD, 534558555 ext. +33, salles.jp@chu-toulouse.fr
Unité Endocrinologie, Nutrition, Diabétologie -Hôpital Bretonneau
Tours, 37044
Lise CRINIERE, MD, lise.criniere@univ-tours.fr
About this study
Official title: Multicentric Retrospective Study on the Use of Cinacalcet in an Off-label Phosphocalcic Context
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.
Read more
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.
- Being tested
- Serum PTH concentrations results
- Keywords
- Hyperparathyroidism, pathology phosphocalcic
- Medical subject headings
- Hyperparathyroidism, Secondary, Hyperparathyroidism, Primary, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum PTH concentrations resultsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cinacalcet | Patients with primary or secondary hyperPTH resulting from phosphocalcic pathology treated by cinacalcet Receives: Other: Serum PTH concentrations results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum PTH concentration
Measured: 3 months after treatment initiation
Secondary outcomes (4)
Serum PTH concentration
Measured: 1 month after treatment initiation
Serum PTH concentration
Measured: 6 months after treatment initiation
Serum PTH concentration
Measured: 12 months after treatment initiation
Serum PTH concentration
Measured: 3 years after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study startJan 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperparathyroidism, SecondaryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justine BACCHETTA, MD, Principal investigator, Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126954
- Sponsor's protocol ID
- 2019_CALCI-CINA
- Acronym
- CALCI-CINA
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Retrospective Study on the Use of Cinacalcet in an Off-label Phosphocalcic Context
- ClinicalTrials.gov ID
- NCT04126954
- Acronym / sponsor ID
- CALCI-CINA / 2019_CALCI-CINA
- Keywords
- Hyperparathyroidism, pathology phosphocalcic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cinacalcet | – | Other: Serum PTH concentrations resultsPatients with primary or secondary hyperPTH resulting from phosphocalcic pathology treated by cinacalcet |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with phosphocalcic diseases suffering from hyperPTH without end-stage renal failure.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum PTH concentrations resultsTo 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. | Other | Cinacalcet |
Primary outcome
Serum PTH concentration
Time frame: 3 months after treatment initiation
4 secondary outcomes
Serum PTH concentration
Time frame: 1 month after treatment initiation
Serum PTH concentration
Time frame: 6 months after treatment initiation
Serum PTH concentration
Time frame: 12 months after treatment initiation
Serum PTH concentration
Time frame: 3 years after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justine BACCHETTA, MD principal investigator
Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperparathyroidism, Secondary and Hyperparathyroidism, Primary, run by Hospices Civils de Lyon at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justine BACCHETTA, MD (4 27 85 61 30 ext. +33, justine.bacchetta@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum PTH concentration (time frame: 3 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.