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

This study has been completed.
Sponsor:
Collaborator:
Albany Medical College
Information provided by (Responsible Party):
Amy Pai PharmD, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier:
NCT00915876
First received: June 5, 2009
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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:

U.S. FDA Resources

Further study details as provided by Albany College of Pharmacy and Health Sciences:

Primary Outcome Measures:
  • The primary outcome measure will be the change in circulating ICAM-1. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
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 mg QD x 8 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo for Paricalcitol 1 mcg QD x 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915876

Locations
United States, New York
Albany Medical Center South Clinical Campus
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany College of Pharmacy and Health Sciences
Albany Medical College
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

No publications provided

Responsible Party: Amy Pai PharmD, Associate Professor, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier: NCT00915876     History of Changes
Other Study ID Numbers: Paricalcitol-AMC2443
Study First Received: June 5, 2009
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Albany College of Pharmacy and Health Sciences:
chronic kidney disease
Vitamin D

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

ClinicalTrials.gov processed this record on May 22, 2013