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

Hypertension Clinical Trial

Official title:

Anti-Inflammatory and Endothelial Protectant Effects of Paricalcitol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428246
• Other study ID #: 0510-04
• Status: Completed
• Phase: N/A
• First received: January 25, 2007
• Last updated: April 6, 2009
• Start date: November 2006
• Est. completion date: July 2007

Study information

• Verified date: April 2009
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Endothelial Dysfunction
• Hypertension
• Inflammation
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• paricalcitol
1 mcg or 2 mcg for 4 weeks.
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Richard A. Rodebush VA Medical Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Abbott

Country where clinical trial is conducted

United States, 

References & Publications (1)

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/HYPE — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Inflammatory Effects of Paricalcitol		6 weeks	No
Primary	Endothelial Protectant Effects of Paricalcitol		6 weeks	No
Secondary	Effect of Paricalcitol on Hypertension		6 weeks	No
Secondary	Effect of Paricalcitol on Kidney Function		6 weeks	No