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

Tracking Information

First Received Date ^ICMJE

June 5, 2009

Last Updated Date

July 10, 2012

Start Date ^ICMJE

March 2009

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00915876 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)

Condition ^ICMJE

Chronic Kidney Disease

Intervention ^ICMJE

Drug: Paricalcitol
paricalcitol 1 mg QD x 8 weeks
Drug: Placebo
Placebo for Paricalcitol 1 mcg QD x 8 weeks

Study Arm (s)

Active Comparator: Paricalcitol
Intervention: Drug: Paricalcitol
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2011

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00915876

Other Study ID Numbers ^ICMJE

Paricalcitol-AMC2443

Has Data Monitoring Committee

Responsible Party

Amy Pai PharmD, Albany College of Pharmacy and Health Sciences

Study Sponsor ^ICMJE

Albany College of Pharmacy and Health Sciences

Collaborators ^ICMJE

Albany Medical College

Investigators ^ICMJE

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

Information Provided By

Albany College of Pharmacy and Health Sciences

Verification Date

July 2012

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

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