proteinuria proteinurie albuminuria albuminurie chronic kidney disease chronisch nierfalen non-diabetic renal disease niet-diabetische nierziekte paricalcitol zemplar vitamin D receptor activator vitamine D receptor activator vitamin D vitamine D
Conditions
Interventions
The study question will be addressed in a prospective, multiple-center, double-blind, crossover, randomized placebo-controlled clinical trial. Patients are consecutively treated during eight weeks wit
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients; 2. Non-diabetic renal disease as established by history, serum biochemistry tests and/or renal biopsy; 3. Age >18 years; 4. Residual proteinuria >300 mg/day and 30 ml/min/1.73m2; with < 6 ml/min per year decline); 6. Average of 2 consecutive PTH values of <8.7 pMol/L, 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; 7. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. 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; 2. Epilepsy; 3. Liver disease resulting in aberrations of liver function tests; 4. Previously treated (within 3 months of screening) with paricalcitol or vitamin D (analogue); 5. Contraindication to ACEi, high/low-sodium diet or paricalcitol; 6. Medication interacting with ACEi or paricalcitol; 7. Frequent NSAID use (>2 doses/week); 8. Use of immunosuppressive drugs; 9. Use of digoxine; 10. Active malignancy; 11. Any bowel disorder resulting in fat malabsorption; 12. 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); 13. Incompliance with diet or study medication; 14. Any psychiatric condition or psychofarmacon use; 15. Drug or alcohol abuse.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean arterial pressure (MAP); 2. Serum creatinine / creatinine clearance; 3. Plasma renin activity (PRA); 4. Renal hemodynamics (measured GFR, ERPF). | — |
Primary
| Measure | Time frame |
|---|---|
| Albuminuria (24-hour urinary albumin excretion). | — |
Contacts
Public ContactA.J. Kwakernaak
P.O. Box 30.001
Outcome results
None listed