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

Conditions: chronic kidney disease
MedDRA version: 12.0Level: LLTClassification code 10064848Term: Chronic kidney disease

Registration Number: EUCTR2009-016159-23-NL

Lead Sponsor: niversity Medical Center Groningen (UMCG)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does paricalcitol have an additive antiproteinuric respons to RAAS blockade and low sodium diet?;Secondary Objective: Does paricalcitol prevent the reactive rise in renin during RAAS-blockade?;Primary end point(s): proteinuria

Secondary Outcome Measures