- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02018133
Identification of Markers for Determining the Efficacy of Vitamin D Receptor Activator Therapy in Stage 3/4 CKD Patients
The purpose of this study is to identify genes that are responsive to paricalcitol (active vitamin D) therapy. Scientists have found that over 30 different types of cells in the body respond to vitamin D therapy, including blood vessels. Low levels of vitamin D may reduce the amount of calcium in the blood, increase the amount of parathyroid hormone (PTH) and cause the parathyroid gland (small gland located in the neck) to get bigger which is called secondary hyperparathyroidism (SHPT). Also, low levels of vitamin D may worsen the heart disease seen in dialysis patients. Paricalcitol, a man-made active vitamin D, is a replacement for vitamin D for preventing and treating SHPT. Studies that followed patients on dialysis have found: (1) differences in death rates between those who received active vitamin D compared with no activated vitamin D, and (2) a survival benefit in chronic kidney disease (CKD) patients receiving paricalcitol, over calcitriol (natural active vitamin D). Researchers have considered that giving paricalcitol to people with (CKD) may also prevent or slow the progression of heart disease.
Currently, physicians can only tell how well the vitamin D is working by measuring PTH concentrations. This study aims to identify markers in the blood that can be used to determine the efficacy of Vitamin D therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After baseline information and laboratory tests are obtained, subjects will be randomized to receive either oral paricalcitol at 2 mcg daily for 2 weeks or placebo. After a washout period of 4 weeks, those subjects who received paricalcitol will receive placebo for 2 weeks and those who received placebo will receive paricalcitol for 2 weeks. A simple blood draw will be obtained from the patient on days 0, 1, and 14 of each treatment arm, and they will also be assessed for side effects at the end of each treatment.
The blood obtained during these visits will be analyzed for any changes that may have occurred in the white blood cells (WBC) and/or plasma. These samples will be tested to see if there are any markers in the blood that changed after treatment with vitamin D. The samples collected will be temporarily stored in the research laboratory and subsequently sent to a separate laboratory (Genus Systems Company) in batches for analysis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Chronic kidney disease stage 3/4
- PTH: >70 pg/ml
- If on ACEI/ARB, optimized and stable dose
Exclusion Criteria:
- Failure to provide informed consent
- Prior active vitamin D oral or parenteral treatment, including calcitriol, paricalcitol and doxercalciferol
- Glomerulonephritis requiring active treatment with immunosuppressive therapy
- Serum phosphorus: > 5.2 mg/dL
- Serum calcium (corrected for albumin): > 10.0 mg/dL
- Clinical unstable medical conditions (other than CKD)
- Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
- History of malignancy, other than basal cell carcinoma of the skin
- History of hypersensitivity to vitamin D or its analogs
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Vitamin D or Placebo
Take vitamin D for 2 weeks.
2mg daily before meal
|
vitamin D 2 capsules daily
Other Names:
placebo 2 capsule daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
examine the gene expression pattern in white blood cells obtained from Stage 3/4 CKD patients before and after paricalcitol treatment
Time Frame: 2 weeks
|
determine gene expression
|
2 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alan Lau, PharmD, University of Illinois at Chicago
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 (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-0929
- BMK-001 (OTHER: Abbott Laboratories)
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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