- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00428246
Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation
Anti-Inflammatory and Endothelial Protectant Effects of Paricalcitol
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Richard A. Rodebush VA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 3
Placebo
|
Placebo
|
Active Comparator: 1
1 mcg paricalcitol
|
1 mcg or 2 mcg for 4 weeks.
Other Names:
|
Active Comparator: 2
2 mcg paricalcitol
|
1 mcg or 2 mcg for 4 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-Inflammatory Effects of Paricalcitol
Time Frame: 6 weeks
|
change in hsCRP level from baseline to 4 weeks
|
6 weeks
|
Endothelial Protectant Effects of Paricalcitol
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect of Paricalcitol on Hypertension
Time Frame: 6 weeks
|
6 weeks
|
Effect of Paricalcitol on Kidney Function
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rajiv Agarwal, MD, Indiana University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0510-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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