Reno- and Vascular Protective Effect of a Vitamin-D-analogue in Moderate to Severe Chronic Kidney Disease

Study Overview
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Brief Summary
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Recently it has been documented that vitamin D has important functions in the human body that are unrelated to its primary effects in calcium homeostasis and bone mineralization. In clinical studies, paricalcitol - a low-calcemic vitamin D analogue - has been shown to decrease proteinuria, a marker of disease progression and cardiovascular risk in patients with chronic kidney disease (CKD). The purpose of this study is to investigate the effect of a paricalcitol on renal and cardiovascular variables in patients with moderate to severe CKD.

Official Title
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Reno- and Vascular Protective Effect of a Low-calcemic Vitamin-D-analogue (Paricalcitol) in Stage III-IV Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: Zemplar
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kidney disease corresponding to eGFR: 15-59 ml/min Albuminuria > 30 mg/l Exclusion Criteria: Total parathyroidectomy Diabetes Mellitus Cancer Illicit drug or alcohol abuse Pregnancy og nursing Ongoing NSAID or corticosteroid treatment b-hemoglobin < 6 mmol/l p-albumin < 25 mmol/l Clinically significant hypercalcemia Office blood pressure > 170/105 mmHg that despite antihypertensive treatment still is > 170/105 mmHg when using home blood pressure measurements or 24-hour ambulatory blood pressure measurement.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paricalcitol<br> | Drug: Zemplar<br>* 2 capsules of 1 microgram daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 2 capsules daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma renin concentration |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary albumin excretion |  | 6 weeks | 
| GFR |  | 6 weeks | 
| Fractional excretion of sodium |  | 6 weeks | 
| Urinary excretion of aquaporin-2 |  | 6 weeks | 
| Urinary excretion of ENaC-beta |  | 6 weeks | 
| Urinary excretion of NCC |  | 6 weeks | 
| Plasma concentration of aldosterone |  | 6 weeks | 
| Plasma concentration of angiotensin-II |  | 6 weeks | 
| Plasma concentration of ADH |  | 6 weeks | 
| Plasma concentration of atrial natriuretic peptide |  | 6 weeks | 
| Plasma concentration of brain natriuretic peptide |  | 6 weeks | 
| Plasma concentration of endothelin |  | 6 weeks | 
| 24-hr ambulatory blood pressure |  | 6 weeks | 
| Central blood pressure |  | 6 weeks | 
| Pulse wave velocity |  | 6 weeks | 
| augmentation index |  | 6 weeks | 
| Plasma concentration of ionized calcium |  | 6 weeks | 
| Plasma concentration of phosphate |  | 6 weeks | 
| Plasma concentration of alkaline phosphatase |  | 6 weeks | 
| Plasma concentration of Parathyroid hormon |  | 6 weeks | 
| Plasma concentration of 25-hydroxy-vitamin D |  | 6 weeks | 
| Plasma concentration of ultrasensitive CRP |  | 6 weeks | 
| Plasma concentration of TNF-alpha |  | 6 weeks | 
| Plasma concentration of TGF-beta |  | 6 weeks | 
| Urinary excretion of calcium |  | 6 weeks | 
| Plasma concentration of ADMA |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paricalcitol, vitamin d, kidney disease, renin, proteinuria