Vascular Reactivity in Chronic Kidney Disease (CKD) Patients Receiving Paricalcitol Versus Placebo

Study Overview
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Brief Summary
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This research is studying how Vitamin D may affect blood vessels reaction to stress and blood levels of substances that may increase blockages in the blood vessels in chronic kidney disease (CKD) patients. Blood vessel health is worsened in CKD and some studies have shown that Vitamin D improves blood vessel health. The type of Vitamin D being used in this study (paricalcitol) is Food and Drug Administration (FDA) approved to treat high parathyroid hormone levels. The purpose of this study is to find out if paricalcitol has other benefits beyond its ability to lower parathyroid hormone levels such as improving the blood vessels reaction to stress and decreasing blood levels of substances that may increase blockages in the blood vessels.

Official Title
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Effects of 19-nor-1α-dihydroxyvitamin D2 (Paricalcitol) Versus Placebo on Oxidative Stress and Vascular Reactivity in CKD Patients

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: Paricalcitol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females ≥ 18 years of age at the start of screening CKD with eGFR 15-60 mL/min/1.73m2 by MDRD Not expected to start dialysis for 4 months Serum intact PTH 70-200 pg/mL during screening period On stable ACEI/ARB regimen for 30 days prior to screening Exclusion Criteria: History of any of the following diseases: congestive heart failure MI within the last 6 months history of cerebrovascular accident significant valvular disease malignancy Currently taking any vitamin D products Mean systolic blood pressure values > 190 or diastolic blood pressure values > 100 mm/Hg during the preceding 30 day period prior to screening Currently being titrated on therapy with an angiotensin converting enzyme inhibitor or angiotensin receptor blocker Two consecutive serum calcium values greater than 10.2 mg/dL or Ca x P > 55 mg2/dL2 Currently receiving erythropoiesis stimulating agent or intravenous iron therapy Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paricalcitol<br> | Drug: Paricalcitol<br>* paricalcitol 1 mcg QD x 8 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo for Paricalcitol 1 mcg QD x 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 | Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56 | Day 28 and Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, Vitamin D