ISRCTN78129473已完成未知
Angiotensin Converting Enzyme (ACE) inhibition for the preservation of renal function and patient survival in kidney transplantation: a randomised, double blind, placebo-controlled trial
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute0 个研究点目标入组 528 人开始时间: 2006年7月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 528
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 16/07/2008:
- •Patients, either sex, who underwent the kidney transplantation and who:
- •1. Have an estimated glomerular filtration rate greater than or equal to 20 ml/min/1.73 m^2 using the Modification of Diet in Renal Disease study (MDRD) equation which has been validated in renal transplant patients
- •2. Have proteinuria = 0.2 grams/day
- •3. Are at least three months post-transplantation
- •4. Have signed informed consent
- •Previous inclusion criteria:
- •Patients, either sex, who underwent the kidney transplantation and who:
- •1. Have an estimated glomerular filtration rate between 20 and 55 ml/min using the Modification of Diet in Renal Disease study (MDRD) equation which has been validated in renal transplant patients
- •2. Have proteinuria = 0.2 grams/day
- •3. Are at least six months post-transplantation
- •4. Have signed informed consent
排除标准
- •1. Unable to provide informed consent
- •2. Less than 18 years old
- •3. Pregnant (ramipril contraindicated)
- •4. Angioedema from an ACE inhibitor or angiotensin receptor blocker or other known reaction to an ACE inhibitor (such as rash, neutropenia or cough)
- •5. Serum potassium greater than 5.5 mmol/l on two or more occasions in the preceding three months for those not on an ACE inhibitor or angiotensin receptor blocker
- •6. Serum potassium greater than 5.9 mmol/l on two or more occasions in the preceding three months for those on an ACE inhibitor or angiotensin receptor blocker
- •7. Left ventricular dysfunction that requires an ACE inhibitor or an angiotensin receptor blocker
- •8. Other severe co-morbid conditions (e.g. malignancy, disabling stroke) with life expectancy less than three months
- •9. New immunosuppressive agent was started or previous immunosuppressant stopped in the three months prior to study entry or plan to switch immunosuppressive agents within next three months
- •10. Had an acute coronary syndrome, stroke or transient ischaemic attack in the three months prior to study entry
- •11. Were previously enrolled in this study
- •12. Currently enrolled in another interventional trial
- •13. Currently on an ACE-inhibitor or an angiotensin receptor blocker and patient or physician unwilling to stop medication
- •14. Had an acute rejection episode in the three months prior to study entry
- •15. Currently on four or more blood pressure pills and have an average blood pressure over three visits greater than 150/100
研究者
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