Vitamin D in addition to RAAS blockade and dietary sodium for the Treatment of Urinary Excretion of albumin: the ViRTUE-study - ViRTUE

niversity Medical Center Groningen (UMCG)0 个研究点开始时间: 2009年10月8日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Male and female patients
•- Non-diabetic renal disease as established by history, serum biochemistry tests and/or renal biopsy
•- Age = 18 and = 75 years
•- Residual proteinuria > 1,0 g/day and < 8 g/day during conventional treatment of at least 8 weeks with ACE-inhibitor or ARB at the maximum recommended dose
•- Stable renal function (creatinine clearance of > 30 ml/min/1.73m2; with < 6 ml/min per year decline)
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Inability to meet inclusion criteria
•- uncontrolled hypertension, hyperkalemia (potassium >6.0 mmol/l, cardiovascular disease (myocardial infarction, unstable angina, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, or stroke within last 6 months, heart failure NYHA III-IV), Diabetes Mellitus
•- epilepsy
•- liver disease resulting in liverfunction aberrations (zemplar bevat ethanol))
•- Previously treated (within 3 months of screening) with paricalcitol or vitamin D
•- contraindication to ACEi, high/low sodium diet or paricalcitol
•- medication interacting with ACEi or paricalcitol
•- frequent NSAID use (>2 doses/week)
•- Immunosuppressive medication
•- Digoxine use
•- secondary or tertiary hyperparathyreoidie
•- active malignancy
•- any bowel disorder resulting in fat malabsorption
•- Pregnant or nursing (lactating) women, where pregnancy is defined as a state of a female after conception and until the termination of gestation, confirmed by a positive ß-hCG laboratory test (>5 mIU/ml).
•- incompliance with diet or study medication
•- any psychiatric condition or psychofarmacon use
•- drug or alcohol abuse

发起方

niversity Medical Center Groningen (UMCG)