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Managing bone and mineral disorders associated with chronic kidney disease (CKD-MBD) in children is a complex task. Controlling parathyroid hormone (PTH) levels involves adjusting calcium intake, managing hyperphosphatemia, intensive dialysis, and considering specific therapies like active vitamin D analogues and cinacalcet.
Cinacalcet, authorized in Europe since 2017 for children over 3 undergoing dialysis with secondary hyperparathyroidism (SHPT), has shown efficacy in reducing PTH levels. The 2019 guidelines call for its use with caution particularly to avoid hypocalcemia, in children with severe hyperparathyroidism despite optimized conventional treatments.
In adults, cinacalcet has been found to reduce serum PTH, calcium, and phosphate levels, decrease the risk of vascular calcification, and have a positive effect on bone formation. This suggests that cinacalcet may slow the progression of cardiovascular calcifications.
Additionally, Professor Shroff has introduced a non-invasive method for assessing bone calcium status by analyzing stable calcium isotope ratios in blood. This method would allow to determine whether a treatment such as cinacalcet has a positive influence on bone calcium balance, a key element in the management of CKD-MBD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children above 3 years of age on maintenance dialysis who begin treatment with cinacalcet | Children above 3 years of age on maintenance dialysis (hemodialysis, hemodiafiltration, peritoneal dialysis) who begin treatment with cinacalcet because of secondary hyperparathyroism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplementary blood samples and urines samples | Biological | Supplementary blood and urines samples realised during routine visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| value of isotope ratios of calcium (44/42 Ca) in blood | value of 44/42 Ca ratio in patients at baseline and, three months after cinacalcet treatment | Baseline / 3 months treatment |
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Inclusion Criteria:
Exclusion Criteria:
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This study will involve children above 3 years of age on maintenance dialysis (hemodialysis, hemodiafiltration, peritoneal dialysis) who begin treatment with cinacalcet.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BACCHETTA Justine, MD | Contact | 0033427856178 | Justine.bacchetta@chu-lyon.fr | |
| FLAMMIER Sacha, MD | Contact | 0033472681349 | Sacha.flammier@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| BACCHETTA Justine, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Pédiatrie CHU de Bordeaux | Recruiting | Bordeaux | 33000 | France |
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Blood : 1 to 3 tubes per visit / 4 visits Urines : 1 tube per visit / 4 visits
| Hôpital Femme Mère Enfant | Recruiting | Bron | 69500 | France |
|
| Service de pédiatrie multidisciplinaire CHU de Montpellier | Recruiting | Montpellier | 34295 | France |
|
| Unité de néphrologie pédiatrique, Hôpital Archet 2, CHU de Nice | Recruiting | Nice | 06202 | France |
|
| Service de Néphrologie pédiatrique Hôpital Necker Enfants Malades | Recruiting | Paris | 75012 | France |
|
| Service de Néphrologie - Transplantation - Hémodialyse pédiatrique Hôpital Robert Debré | Recruiting | Paris | 75019 | France |
|
| Service de pédiatrie 1 CHU Hautepierre | Recruiting | Strasbourg | 67000 | France |
|
| ID | Term |
|---|---|
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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