Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation - Full Text View

Sponsors and Collaborators:	Indiana University School of Medicine Abbott
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00428246

Purpose

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.

Condition	Intervention
Chronic Kidney Disease Endothelial Dysfunction Inflammation Hypertension	Drug: paricalcitol

MedlinePlus related topics: High Blood Pressure

Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Official Title:	Anti-Inflammatory and Endothelial Protectant Effects of Paricalcitol

Further study details as provided by Indiana University:

Primary Outcome Measures:

Anti-inflammatory effects of paricalcitol
Endothelial protectant effects of paricalcitol

Secondary Outcome Measures:

Effect of paricalcitol on hypertension
Effect of paricalcitol on kidney function

Estimated Enrollment:	24
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2007

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428246

Contacts

Contact: Rajiv Agarwal, MD	317-988-2241	ragarwal@iupui.edu
Contact: Pooneh Alborzi, MD	317-312-1395 (pager)	palborzi@iupui.edu

Locations

United States, Indiana
Richard A. Rodebush VA Medical Center	Recruiting
indianapolis, Indiana, United States, 46202
Contact: Rajiv Agarwal, MD 317-988-2241 ragarwal@iupui.edu
Contact: Pooneh Alborzi, MD 317-312-1395 palborzi@iupui.edi

Sponsors and Collaborators

Indiana University School of Medicine

Abbott

Investigators

Principal Investigator:

Rajiv Agarwal, MD

Indiana University School of Medicine

More Information

No publications provided by Indiana University

Publications automatically indexed to this study:

Alborzi P, Patel NA, Peterson C, Bills JE, Bekele DM, Bunaye Z, Light RP, Agarwal R. Paricalcitol reduces albuminuria and inflammation in chronic kidney disease: a randomized double-blind pilot trial. Hypertension. 2008 Aug;52(2):249-55. Epub 2008 Jul 7.

Study ID Numbers:	0510-04
Study First Received:	January 25, 2007
Last Updated:	January 26, 2007
ClinicalTrials.gov Identifier:	NCT00428246
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

Chronic Kidney Disease
Endothelial dysfunction
Inflammation
Hypertension

paricalcitol
Blood pressure
Vitamin D
Glomerular filtration rate

Study placed in the following topic categories:

Cholecalciferol
Renal Insufficiency
Vitamin D
Urologic Diseases
Renal Insufficiency, Chronic
Ergocalciferols

Vascular Diseases
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure
Inflammation
Hypertension

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2009