chronic kidney disease MedDRA version: 12.0 Level: LLT Classification code 10064848 Term: Chronic kidney disease
Conditions
Interventions
Trade Name: paricalcitol
Product Name: paricalcitol
Product Code: RVG 100436
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
University Medical Center Groningen (UMCG)
Eligibility
Sex/Gender
All
Inclusion criteria
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 30 ml/min/1.73m2; with =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed