Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet - The Cin-Ca Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 14
- 主要终点
- value of isotope ratios of calcium (44/42 Ca) in blood
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 3 to 17 years of age
- •On maintenance dialysis : hemodialysis, hemodiafiltration, peritoneal dialysis
- •Patient who begin treatment with cinacalcet based on the 2019 European guidelines and at the discretion of the treating physician
- •With normal QTc interval on electrocardiogram
- •With total serum calcium >2.40 mmol/L
- •With heamoglobin > 8g/dl
- •Non - opposition from parents/legal guardians
排除标准
- •Children < 12 kg
- •Persons deprived of their liberty by a judicial or administrative decision
- •Persons under psychiatric care
- •Persons admitted to a health or social institution for purposes other than research
- •Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- •Persons participating in other interventional research with an exclusion period still in progress at pre-inclusion
- •Patients who received cinacalcet with 3 months prior inclusion
研究组 & 干预措施
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
干预措施: Supplementary blood samples and urines samples (Biological)
结局指标
主要结局
value of isotope ratios of calcium (44/42 Ca) in blood
时间窗: Baseline / 3 months treatment
value of 44/42 Ca ratio in patients at baseline and, three months after cinacalcet treatment
次要结局
未报告次要终点