Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation
Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease; Endothelial Dysfunction; Inflammation; Hypertension
Intervention: paricalcitol (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Indiana University School of Medicine Official(s) and/or principal investigator(s): Rajiv Agarwal, MD, Principal Investigator, Affiliation: Indiana University School of Medicine
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.
Clinical Details
Official title: Anti-Inflammatory and Endothelial Protectant Effects of Paricalcitol
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Anti-Inflammatory Effects of ParicalcitolEndothelial Protectant Effects of Paricalcitol
Secondary outcome: Effect of Paricalcitol on HypertensionEffect of Paricalcitol on Kidney Function
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Richard A. Rodebush VA Medical Center, Indianapolis, Indiana 46202, United States
Additional Information
Starting date: November 2006
Last updated: April 6, 2009
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