A Prospective, Randomized Trial to Compare Subtotal Parathyroidectomy Versus Cinacalcet in the Treatment of Persistent Secondary Hyperparathyroidism Post Renal Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in blood calcium levels
研究概览
简要总结
The hypothesis of this study is that subtotal parathyroidectomy using minimally invasive surgery is superior to cinacalcet for the treatment of persistent secondary hyperparathyroidism (HPT) post renal transplant, with minimal morbidity and significantly reduces the cost of treatment post transplant.
详细描述
Persistent hyperparathyroidism (HPT) with hypercalcemia is prevalent after transplant (affects up to 25% of patients) and negatively affects graft and patient outcome. The subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet. Several studies guarantee that cinacalcet is effective in controlling hypercalcemia derived of persistent HPT after renal transplantation. However, maintenance treatment is need because hypercalcemia increases quickly after treatment is stopped. This fact makes increase a lot the cost of transplantation in these patients.
The hypothesis of this study is that subtotal parathyroidectomy by minimally invasive surgery is superior to cinacalcet for treatment of persistent secondary HPT post renal transplant, with minimal morbidity and significantly reduces the cost of treatment after transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functioning renal transplant, GFR ≥ 30 ml / min
- •Time post-transplant> 6 months
- •PTHi>15pmol/L
- •Calcium ≥2.63 mmol/L con phosphatemia ≤1.2 mmol/L
- •Cervical scintigraphy
- •Signed informed consent
排除标准
- •Contraindication to surgery
研究组 & 干预措施
Subtotal parathyroidectomy
The procedure of choice is subtotal parathyroidectomy if the intraoperative biopsy confirms multiglandular disease and at least 3 glands are removed leaving a remanent of one normal gland
干预措施: Subtotal parathyroidectomy (Procedure)
Cinacalcet
Cinacalcet is initiated at a dose of 30 mg per day PO, adjusting the dose monthly (up to 90 mg per day PO) to achieve normocalcemia
干预措施: Cinacalcet (Drug)
结局指标
主要结局
Change in blood calcium levels
时间窗: 12 months
Change from baseline in blood calcium levels at 12 months.
次要结局
- Change in parathyrin blood levels(6 months)
- Patient and graft survival(12 months)
- Economic evaluation of interventions measured by money spend in it.(12 months)
- Estimated glomerular filtration rate.(12 months)
- Change in blood calcium levels(6 months)
研究者
Josep M Cruzado
Nephrologist
Hospital Universitari de Bellvitge