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

October 7, 2016 updated by: Amy Barton Pai

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center South Clinical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo for Paricalcitol 1 mcg QD x 8 weeks
Active Comparator: Paricalcitol
Drug: Paricalcitol
paricalcitol 1 mcg QD x 8 weeks

What is the study measuring?

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
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
Day 28 and Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amy Barton Pai

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 8, 2009

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Paricalcitol-AMC2443

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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