Clinical trial NCT00428246: Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation
Official title: Anti-Inflammatory and Endothelial Protectant Effects of Paricalcitol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Endothelial Dysfunction
Inflammation
Hypertension
Keywords: Chronic Kidney Disease
Endothelial dysfunction
Inflammation
Hypertension
paricalcitol
Blood pressure
Vitamin D
Glomerular filtration rate
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2007-01-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Anti-Inflammatory Effects of Paricalcitol
timeFrame: 6 weeks
measure: Endothelial Protectant Effects of Paricalcitol
timeFrame: 6 weeks
Secondary outcomes:
measure: Effect of Paricalcitol on Hypertension
timeFrame: 6 weeks
measure: Effect of Paricalcitol on Kidney Function
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard A. Rodebush VA Medical Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Rajiv Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1161/HYPERTENSIONAHA.108.113159. Epub 2008 Jul 7.