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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-12-31

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.

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paricalcitol

Group Type ACTIVE_COMPARATOR

Zemplar

Intervention Type DRUG

2 capsules of 1 microgram daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 capsules daily

Interventions

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Zemplar

2 capsules of 1 microgram daily

Intervention Type DRUG

Placebo

2 capsules daily

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No