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

Study Overview
=================
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.

Official Title
-----------------
Anti-Inflammatory and Endothelial Protectant Effects of Paricalcitol

Conditions
-----------------
Chronic Kidney Disease, Endothelial Dysfunction, Inflammation, Hypertension

Intervention / Treatment
-----------------
* Drug: paricalcitol
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>1 mcg paricalcitol | Drug: paricalcitol<br>* 1 mcg or 2 mcg for 4 weeks.<br>* Other names: Zemplar;|
| Active Comparator: 2<br>2 mcg paricalcitol | Drug: paricalcitol<br>* 1 mcg or 2 mcg for 4 weeks.<br>* Other names: Zemplar;|
| Placebo Comparator: 3<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Inflammatory Effects of Paricalcitol | change in hsCRP level from baseline to 4 weeks | 6 weeks | 
| Endothelial Protectant Effects of Paricalcitol |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Paricalcitol on Hypertension |  | 6 weeks | 
| Effect of Paricalcitol on Kidney Function |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, Endothelial dysfunction, Inflammation, Hypertension, paricalcitol, Blood pressure, Vitamin D, Glomerular filtration rate