owering total homocysteine using vitamins to slow the progression of diabetic nephropathy: a randomised controlled trial

John P. Robarts Research Institute (Canada)0 个研究点目标入组 300 人开始时间: 2005年9月1日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Type I or type II diabetes mellitus
•2. Clinical or histological diagnosis of diabetic nephropathy
•3. Urinary albumin excretion level of at least 300 mg/day or urinary protein level of at least 500 mg/day (based upon a 24 hour urine collection) within the past 24 months
•4. Patient is able and willing to give informed consent
•5. Over the age of 18 years old, either sex
•6. Individual patient co-operation is obtained for regular follow-up until completion of the trial

•1. Patient starting on an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker who has been taking the drug for less than three months. (After a three-month time period the patient may then be considered eligible for the trial).
•2. Patient not expected to survive three years because of intercurrent cancer or other severe illness
•3. Patient expected to be non-compliant; who will not adhere to the study visit protocol, who will not take the study vitamins or who will not discontinue previous multivitamin or B-complex vitamin use
•4. Patient on dialysis or imminently expected to require dialysis
•5. Other known renal disease that may impact on progression rate (i.e. renal artery stenosis or glomerular renal disease such as membranous nephropathy)
•6. Women of childbearing potential who are unwilling to practice a form of birth control for the duration on the trial deemed appropriate by the Investigator
•7. Patient with a creatinine clearance of less than 30 ml/min based on the Cockcroft-Gault method or less than 25 ml/min if the patient is currently on an ACE inhibitor or angiotensin receptor blocker (within 30 days prior to randomization if less than 35 ml/min or within 6 months if greater than or equal to 35 ml/min)

发起方

John P. Robarts Research Institute (Canada)