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临床试验/EUCTR2011-006120-20-SI
EUCTR2011-006120-20-SI进行中(未招募)不适用

Efficacy and safety of selective vitamin D receptor activation with paricalcitol for reduction of proteinuria in kidney transplant recipients: a randomized controlled trial - Paricalcitol for reduction of proteinuria in kidney transplant recipients

niversity Medical Centre Ljubljana0 个研究点开始时间: 2012年1月10日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Recipients of a deceased donor kidney transplant at least three months after transplantation.
  • Patients are on stable immunosuppression at least three months before study enrollment.
  • Recipient age = 18 years.
  • Patients are on stable doses of antihypertensive medications for at least three months before study enrollment.
  • Patients are not expected to begin dialysis for at least six months.
  • Estimated glomerular filtration rate > 15 mL/min/1.73 m2.
  • UPCR > 22 mg/mmol (> 200 mg/g), as determined by the geometric mean of three second morning void urine samples.
  • Corrected serum calcium concentration = 2.5 mmol/L.
  • Intact parathoromone concentration > 35 pg/mL.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 156
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • Patients on vitamin D receptor activation therapy within three months prior to the first study visit.
  • Patients with diagnosis of primary focal segmental glomerulosclerosis (FSGS).
  • Patients with acute kidney injury within three months prior to the first study visit.
  • Patients with poorly controlled hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg).

研究者

发起方
niversity Medical Centre Ljubljana

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