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临床试验/NCT00646282
NCT00646282终止4 期

Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney

Emory University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
12
试验地点
1
主要终点
Number of Subjects With 50% Reduction of Intact Parathyroid Hormone (iPTH) Levels

研究概览

简要总结

Patients with kidney failure on dialysis can be successfully transplanted. However, many of them do not attain a normal kidney function and/or present a slow deterioration of kidney function after transplantation. As a consequence, they can develop an endocrine disorder called hyperparathyroidism, which can cause bone disease and a high risk of bone fractures. In spite of the known bone disease and hyperparathyroidism, there is no well defined treatment for these patients.

Moreover, kidney transplant recipients present a higher mortality rate compared to the general population, and the principal cause of death is cardiovascular disease. Dialysis patients are known to have extensive cardiovascular calcifications and increased vascular stiffness, and these factors have been closely associated with cardiovascular mortality.

The effect of vitamin D on bone health is well known in the general population. Many studies showed a reduction in fracture rate in post-menopausal women and older men receiving vitamin D and calcium supplements. Vitamin D analogues are also commonly used to treat hyperparathyroidism in dialysis patients. Finally, vitamin D has been suggested to have beneficial effects on the cardiovascular system and to reduce mortality in dialysis patients.

Hectorol® is a vitamin D analog which has been demonstrated to effectively treat hyperparathyroidism in dialysis and pre-dialysis patients.

The effects of vitamin D supplementation on bone disease, hyperparathyroidism and cardiovascular function in kidney transplant recipients have not been properly studied.

Whether Hectorol® therapy helps reducing the severity of bone disease and improving vascular function in kidney transplant recipients is still unknown.

详细描述

The investigators plan to study the cardiovascular and bone effects of Hectorol® in 100 kidney transplant recipients. The kidney transplant patients will be screened for kidney transplant dysfunction and hyperparathyroidism. The study medication will be given to 50 patients. The other 50 patients will continue to be treated with the actual standard of care at the transplant clinic. Subjects will be followed for 18 months and their laboratory values, bone density, vascular calcification and stiffness will be collected to see if there is an effect of Hectorol® compared to the actual standard of care.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Kidney transplant recipient > 18 year/old with reduced and stable kidney function (estimated GFR 25-60 ml/min/1.73m2)
  • iPTH levels between 120 and 500 pg/ml
  • Stable immunosuppressive therapy (5-10 mg Prednisone/day, stable dosage of calcineurin inhibitors, or other immunosuppressive agents for at least 6 months)

排除标准

  • Recent rejection episode (< 3 months)
  • One of the following: baseline estimated GFR>60 ml/min/1.73m2 or <25 ml/min/1.73m2, albumin-corrected Ca>9.5 mg/dl or serum phosphorus >4.6 mg/dl.
  • Recipients of dual transplant organs with exception of kidney-pancreas
  • Patients already receiving treatment with Vitamin D analogues
  • Severe peripheral vascular disease or coronary artery disease
  • History of previous parathyroidectomy
  • Current alcohol or drug abuse
  • Pregnant or nursing woman or female of child-bearing age not receiving contraception
  • Other comorbidities that in the opinion of the investigators would reduce expected patient's survival and preclude study completion
  • Medications that could interfere with Hectorol® metabolism

研究组 & 干预措施

Doxercalciferol

Experimental

Stable kidney transplant recipients will receive Doxercalciferol

干预措施: doxercalciferol (Drug)

结局指标

主要结局

Number of Subjects With 50% Reduction of Intact Parathyroid Hormone (iPTH) Levels

时间窗: 18 months

Number of participants that have 50% reduction in iPTH levels (but not lower than 65 pg/ml) at 18 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Guasch, M.D.

Professor

Emory University

研究点 (1)

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