Vitamin D in addition to RAAS blockade and dietary sodium for the Treatment of Urinary Excretion of albumin.

Phase 3

Completed

Conditions: albuminuria
chronische nierinsufficientie (excl. diabetische nefropathie)
urinary loss of protein

Registration Number: NL-OMON40020

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

- male and female patients
- non-diabetic renal disease as established by history, serum biochemistry tests and/or renal
biopsy
- 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
decline)
- 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

Exclusion 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 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Albuminuria (24-hour urinary albumin excretion)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- mean arterial pressure (MAP)<br /><br>- serum creatinine / creatinine clearance<br /><br>- PRA (plasma renin activity)<br /><br>- renal hemodynamics (measured GFR, ERPF)</p><br>