Treatment of Secondary Hyperparathyroidism in the Uremic Patient. A Study Comparing Alfacalcidol and Paricalcitol
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 8
- 主要终点
- The effect of alfacalcidol and paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia and hypercalcemia
研究概览
简要总结
The purpose of this study is to compare alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients.
详细描述
Secondary hyperparathyroidism is a common feature in patients with chronic kidney disease. Its clinical consequences include renal osteodystrophy, calciphylaxia and potentially vascular calcifications with increased morbidity and mortality.
Reduced synthesis of active vitamin D contributes to secondary hyperparathyroidism. Therefore we primarily manage this condition with activated vitamin D. In Denmark alfacalcidol is the primary choice of vitamin D analog.
However hypercalcemia and hyperphosphatemia may limit the use of alfacalcidol therapy due to increased risk of vascular calcification and mortality.
Therefore a new vitamin D analog, paricalcitol, has been developed, that may be less prone to develop hypercalcemia and hyperphosphatemia.
However a randomised controlled clinical study comparing alfacalcidol and paricalcitol has never been performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •Secondary hyperparathyroidism; iPTH > 350 pg/ml before any treatment or after 6 weeks without any treatment with vitamin D.
- •Chronic renal insufficiency receiving hemodialysis.
- •P-phosphate < 1,8 mmol/l
- •P-calcium ion < 1,25 mmol/l
- •Receiving maximal possible dose of calcium-based phosphate binder.
- •Accepting 2 x 6 weeks without vitamin D.
- •Safe anti conception in fertile women
- •Do not expect need of calcimimetics or parathyroidectomy during the next year.
- •Written informed consent.
排除标准
- •Disease or condition making the patient unable to participate
- •Expected lifetime less than one year.
- •Pregnancy and nursing
- •Allergic to contents of Zemplar or Etalpha
- •Currently receiving calcimimetics
- •Participating in other clinical intervention studies
研究组 & 干预措施
1
alfacalcidol 16 weeks, 6 weeks wash out, paricalcitol 16 weeks
干预措施: paricalcitol (Drug)
2
paricalcitol ´16 weeks, 6 weeks wash out, alfacalcidol 16 weeks
干预措施: alfacalcidol (Drug)
结局指标
主要结局
The effect of alfacalcidol and paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia and hypercalcemia
时间窗: 16 weeks
次要结局
- alkaline phosphatase, 25OH-vitamin D,1,25 OH2-vitamin D,calcium x phosphate product, blood pressure, pulse, pulse pressure, parathyroidectomy, pulse wave velocity and pulse wave analysis, initiation of treatment with calcimimetics.(16 weeks)