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

NCT ID: NCT00915876

Last Updated: 2016-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-03-31

Brief Summary

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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

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Conditions

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Chronic Kidney Disease

Keywords

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chronic kidney disease Vitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

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Paricalcitol

Group Type ACTIVE_COMPARATOR

Paricalcitol

Intervention Type DRUG

paricalcitol 1 mcg QD x 8 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for Paricalcitol 1 mcg QD x 8 weeks

Interventions

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Paricalcitol

paricalcitol 1 mcg QD x 8 weeks

Intervention Type DRUG

Placebo

Placebo for Paricalcitol 1 mcg QD x 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albany College of Pharmacy and Health Sciences

OTHER

Sponsor Role collaborator

Amy Barton Pai

OTHER

Sponsor Role lead

Responsible Party

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Amy Barton Pai

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Amy Pai, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Albany College of Pharmacy and Health Sciences

Amy Pai, PharmD

Role: PRINCIPAL_INVESTIGATOR

Albany College of Pharmacy and Health Sciences

Locations

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Albany Medical Center South Clinical Campus

Albany, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Paricalcitol-AMC2443

Identifier Type: -

Identifier Source: org_study_id