Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation
Primary Purpose
Chronic Kidney Disease, Endothelial Dysfunction, Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
paricalcitol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Endothelial dysfunction, Inflammation, Hypertension, paricalcitol, Blood pressure, Vitamin D, Glomerular filtration rate
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
Sites / Locations
- Richard A. Rodebush VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
1 mcg paricalcitol
2 mcg paricalcitol
Placebo
Outcomes
Primary Outcome Measures
Anti-Inflammatory Effects of Paricalcitol
change in hsCRP level from baseline to 4 weeks
Endothelial Protectant Effects of Paricalcitol
Secondary Outcome Measures
Effect of Paricalcitol on Hypertension
Effect of Paricalcitol on Kidney Function
Full Information
NCT ID
NCT00428246
First Posted
January 25, 2007
Last Updated
April 6, 2009
Sponsor
Indiana University School of Medicine
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT00428246
Brief Title
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
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Indiana University School of Medicine
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Endothelial Dysfunction, Inflammation, Hypertension
Keywords
Chronic Kidney Disease, Endothelial dysfunction, Inflammation, Hypertension, paricalcitol, Blood pressure, Vitamin D, Glomerular filtration rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
1 mcg paricalcitol
Arm Title
2
Arm Type
Active Comparator
Arm Description
2 mcg paricalcitol
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
paricalcitol
Other Intervention Name(s)
Zemplar
Intervention Description
1 mcg or 2 mcg for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Anti-Inflammatory Effects of Paricalcitol
Description
change in hsCRP level from baseline to 4 weeks
Time Frame
6 weeks
Title
Endothelial Protectant Effects of Paricalcitol
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Effect of Paricalcitol on Hypertension
Time Frame
6 weeks
Title
Effect of Paricalcitol on Kidney Function
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajiv Agarwal, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard A. Rodebush VA Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18606901
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.
Results Reference
result
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Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation
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