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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00915876
First Posted: June 8, 2009
Last Update Posted: December 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Albany College of Pharmacy and Health Sciences
Information provided by (Responsible Party):
Amy Barton Pai, University of Michigan
  Purpose
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.

Condition Intervention
Chronic Kidney Disease Drug: Paricalcitol Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Effects of 19-nor-1α-dihydroxyvitamin D2 (Paricalcitol) Versus Placebo on Oxidative Stress and Vascular Reactivity in CKD Patients

Resource links provided by NLM:


Further study details as provided by Amy Barton Pai, University of Michigan:

Primary Outcome Measures:
  • Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 [ Time Frame: 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


Enrollment: 41
Study Start Date: March 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paricalcitol Drug: Paricalcitol
paricalcitol 1 mcg QD x 8 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo for Paricalcitol 1 mcg QD x 8 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915876


Locations
United States, New York
Albany Medical Center South Clinical Campus
Albany, New York, United States, 12208
Sponsors and Collaborators
Amy Barton Pai
Albany College of Pharmacy and Health Sciences
Investigators
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
  More Information

Responsible Party: Amy Barton Pai, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00915876     History of Changes
Other Study ID Numbers: Paricalcitol-AMC2443
First Submitted: June 5, 2009
First Posted: June 8, 2009
Results First Submitted: October 7, 2016
Results First Posted: December 2, 2016
Last Update Posted: December 2, 2016
Last Verified: October 2016

Keywords provided by Amy Barton Pai, University of Michigan:
chronic kidney disease
Vitamin D

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents