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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Endothelial Dysfunction; Inflammation; Hypertension
• Interventions: Drug: Placebo; Drug: paricalcitol

• Registration Number: NCT00428246
• Lead Sponsor: Indiana University School of Medicine

Brief Summary

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.

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-01-26
• Study First Posted: 2007-01-29
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2009-04
• Results First Submitted: 2009-04-06
• Results First Submitted QC: 2009-04-06
• Last Update Submitted: 2009-04-06
• Results First Posted: 2009-06-03
• Last Update Posted: 2009-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3	Placebo	Placebo
1	paricalcitol	1 mcg paricalcitol
2	paricalcitol	2 mcg paricalcitol

Primary Outcome Measures

Name	Time	Method
Anti-Inflammatory Effects of Paricalcitol	6 weeks	change in hsCRP level from baseline to 4 weeks
Endothelial Protectant Effects of Paricalcitol	6 weeks

Secondary Outcome Measures

Name	Time	Method
Effect of Paricalcitol on Hypertension	6 weeks
Effect of Paricalcitol on Kidney Function	6 weeks

Trial Locations

Locations (1)

Richard A. Rodebush VA Medical Center; 🇺🇸 Indianapolis, Indiana, United States