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

Phase 2

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Zemplar; Drug: Placebo

• Registration Number: NCT01136564
• Lead Sponsor: Erling Bjerregaard Pedersen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Study Start: 2010-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-24
• Last Update Posted: 2012-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Paricalcitol	Zemplar	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
plasma renin concentration	6 weeks

Secondary Outcome Measures

Name	Time	Method
Urinary excretion of NCC	6 weeks
Urinary excretion of calcium	6 weeks
Plasma concentration of ADMA	6 weeks
Urinary excretion of aquaporin-2	6 weeks
Urinary excretion of ENaC-beta	6 weeks
Urinary albumin excretion	6 weeks
GFR	6 weeks
Fractional excretion of sodium	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

Trial Locations

Locations (1)

Department of Medical Research; 🇩🇰 Holstebro, Denmark