Parathyroid Hormone Level and Growth in Pediatric Patients With ESRD on Regular Hemodialysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- correlation between PTH and serum IGF-1
研究概览
简要总结
Chronic kidney disease (CKD) is defined as either renal damage and/ or a glomerular filtration rate (GFR) below 60 mL/min/1.73 m2 for more than 3 months. End stage renal disease (ESRD) is defined as GFR below 15 mL/min/1.73 m2.
Secondary hyperparathyroidism (SHPT) is an insidious disease that develops early in the course of CKD and increase in severity as the GFR deteriorates. High serum levels of intact parathyroid hormone (iPTH) are known to cause high turnover bone disease, i.e. osteitis fibrosa and have also been reported to increase the mortality risk in patients undergoing hemodialysis (HD).
Standard therapy for SHPT includes dietary calcium supplementation, active vitamin D, and phosphate binders; however, these are often insufficient to allow patients to achieve their serum parathyroid hormone (PTH), calcium and calcium-phosphorus product (Ca × P) targets.
Recent preclinical studies have demonstrated that treatment with calcimimetics that increase the sensitivity of the calcium-sensing receptor (CaR) to calcium can reverse the alterations in CaR and vitamin D receptor expression and parathyroid cell proliferation that are associated with SHPT.
Calcimimetics such as cinacalect are positive allosteric modulators of the calcium-sensing receptor that increase its sensitivity by lowering the threshold for activation by extracellular calcium ions. The calcimimetic cinacalcet mainly increases the sensitivity of the CaR to extracellular Ca, thus inhibiting the release of PTH, although, as recently shown, it also decreases PTH synthesis.
Growth hormone (GH) indirectly promotes the growth of child by stimulating the production of insulin like growth factor (IGF-1), many children with renal disease have normal or elevated level of GH in their blood otherwise the levels of IGF-1 are low because the approximately 98% of IGF-1 is always bound to one of binding proteins (BP) inside the liver, so this accumulated protein will reduce the function of IGF-1.
Using cinacalcet in controlling hyperparathyroidism may reduce growth problems in children with ESRD with regular hemodialysis.
详细描述
This interventional study will be conducted at Nephrology Unit Pediatric Department Tanta University Hospital (TUH) for a period of 6 months starting from August 2023.
Study duration 6 months from August 2023 to February 2024. Place of the study: Nephrology Unit at TUH. Study sample: This study will be conducted on 35 children and adolescents with end stage renal disease on regular hemodialysis for three to four times weekly at our nephrology Unit at TUH during the period of the study.
Inclusion criteria:
Pediatric patients with end stage renal disease aged from 8 to 18 years on regular hemodialysis.
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients with end stage renal disease aged from 5 to 18 years on regular hemodialysis.
排除标准
- •Controlled hyperparathyroidism- PTH <300 pg/ml.
- •Children < 8y.
- •Previous parathyroidectomy
- •children on growth hormone therapy
研究组 & 干预措施
35 children and adolescents with end stage renal disease on regular hemodialysis
All children will receive cinacalcet in a dose of 30 mg/day taken with food for 3 months
干预措施: Cinacalcet (Drug)
结局指标
主要结局
correlation between PTH and serum IGF-1
时间窗: 3 months
correlation between serum levels of parathyroid hormone and serum insulin like growth factor-1 in pediatric patients with ESRD on regular hemodialysis
次要结局
- Cinacalcet effect on level of IGF-1(3 months)
研究者
Sara Mabrouk Elghoul
Principal Investigator, Clinical Lecturer of Pediatric Nephrology
Tanta University