Vitamin D in addition to RAAS blockade and dietary sodium for the Treatment of Urinary Excretion of albumin. - Additive antialbuminuric effect of vitamine D: The ViRTUE-study.

niversitair Medisch Centrum Groningen0 个研究点目标入组 45 人开始时间: 待定最近更新: 2024年5月6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
•- age >=18 years
•- residual albuminuria >300 mg/day and <10 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
•- average of 2 consecutive PTH values of < 1.5 times the upper limit of normal (defined by the reference values of each participating center), 2 consecutive serum calcium levels
•between 2.0 and 2.6 mmol/l (corrected for albumin levels), 2 consecutive serum phosphorus
•levels of 1.5 mmol/l within 4 weeks prior to treatment
•- written informed consent

•- 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 aberrations of liver function tests
•- previously treated (within 3 months of screening) with paricalcitol or vitamin D (analogue)
•- contraindication to ACEi, high/low-sodium diet or paricalcitol
•- medication interacting with ACEi or paricalcitol
•- frequent NSAID use (>2 doses/week)
•- use of immunosuppressive drugs
•- use of digoxine
•- 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

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