Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-07-31

Brief Summary

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The study is about possible protective effects of paricalcitol (Zemplar) upon inflammation, blood pressure and kidney function. Kidney Inflammation occurs when white blood cells become abnormally stimulated and accumulate in the kidney and cause damage to the kidney. The purpose of this study is to determine if paricalcitol helps improve kidney injury, blood pressure control and kidney function in patients with chronic kidney disease. The study will last about 7 weeks and involves about 8 visits to the medical center.

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Detailed Description

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We hypothesize that use of paricalcitol in patients with chronic kidney disease will lead to improvement in oxidative stress, inflammation, endothelial function and subsequently ambulatory blood pressures and glomerular filtration rate. We will pursue our hypothesis by the three specific aims:

Aim 1: To compare oxidative stress markers in patients treated with paricalcitol before and after the study. Aim 2: To measure endothelial function by flow mediated dilation in patients with chronic kidney disease before and after paricalcitol. Aim 3: To measure actigraphy guided ambulatory blood pressure and GFR in the absence of changes in anti-hypertensive medications in patients with chronic kidney disease.

The study will be double blind randomized pilot trial in 24 patients with chronic kidney disease with 1:1:1 allocation to paricalcitol 1 microgram: paricalcitol 2 microgram: Placebo.

Conditions

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Chronic Kidney Disease Endothelial Dysfunction Inflammation Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

1 mcg paricalcitol

Group Type ACTIVE_COMPARATOR

paricalcitol

Intervention Type DRUG

1 mcg or 2 mcg for 4 weeks.

2

2 mcg paricalcitol

Group Type ACTIVE_COMPARATOR

paricalcitol

Intervention Type DRUG

1 mcg or 2 mcg for 4 weeks.

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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paricalcitol

1 mcg or 2 mcg for 4 weeks.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Zemplar

Eligibility Criteria

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Inclusion Criteria

* Patients with chronic kidney disease with estimated GFR of 30 mL/minute or more.
* Patients receiving stable dose of ACE inhibitor or Angiotensin receptor blockers for at least one month.
* Patients not currently hypertensive more than 180/110 mmHg by clinic blood pressure.
* Hemoglobulin A1C\< 11%

Exclusion Criteria

* Patients taking vitamin D analogs
* Calcium\> 10 mg/dL
* Phosphorus\>6 mg/dL
* Patients with anticipated need of dialysis in the next 6 weeks
* Patients unstable in the opinion of the investigator
* Patients who have emergent need for starting IV iron
* Patients who will be started on statins within the next 6 weeks
* Patients currently taking PDE5 inhibitors
* Patients allergic to radiocontrast, Zemplar or who can not take nitroglycerin
* Patients known to be HIV positive
* Patients who can not give informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No