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

Indiana University School of Medicine

Status: Completed

Conditions: Chronic Kidney Disease; Hypertension; Inflammation; Endothelial Dysfunction

Treatments: Drug: Placebo; Drug: paricalcitol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00428246

0510-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

1 mcg paricalcitol

Treatment:

Drug: paricalcitol

2

Active Comparator group

Description:

2 mcg paricalcitol

Treatment:

Drug: paricalcitol

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo