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

This study has been completed.
Sponsor:
Collaborator:
Albany College of Pharmacy and Health Sciences
Information provided by (Responsible Party):
Amy Barton Pai, University of Michigan
ClinicalTrials.gov Identifier:
NCT00915876
First received: June 5, 2009
Last updated: October 7, 2016
Last verified: October 2016

June 5, 2009
October 7, 2016
March 2009
March 2011   (final data collection date for primary outcome measure)
Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 [ Time Frame: Day 28 and Day 56 ] [ Designated as safety issue: No ]
Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56
The primary outcome measure will be the change in circulating ICAM-1. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00915876 on ClinicalTrials.gov Archive Site
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Vascular Reactivity in Chronic Kidney Disease (CKD) Patients Receiving Paricalcitol Versus Placebo
Effects of 19-nor-1α-dihydroxyvitamin D2 (Paricalcitol) Versus Placebo on Oxidative Stress and Vascular Reactivity in CKD Patients
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.
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Interventional
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Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Chronic Kidney Disease
  • Drug: Paricalcitol
    paricalcitol 1 mcg QD x 8 weeks
  • Drug: Placebo
    Placebo for Paricalcitol 1 mcg QD x 8 weeks
  • Active Comparator: Paricalcitol
    Intervention: Drug: Paricalcitol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00915876
Paricalcitol-AMC2443
No
Not Provided
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Amy Barton Pai, University of Michigan
Amy Barton Pai
Albany College of Pharmacy and Health Sciences
Principal Investigator: Amy Pai, Pharm.D. Albany College of Pharmacy and Health Sciences
Principal Investigator: Amy Pai, PharmD Albany College of Pharmacy and Health Sciences
University of Michigan
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP