Evaluate the Survival Benefits of Zemplar Versus Calcijex in Subjects w/ Stage V Chronic Kidney Disease on Hemodialysis

NCT ID: NCT00062699

Last Updated: 2006-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Brief Summary

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To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney disease on hemodialysis as measured by time to death.

Detailed Description

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Conditions

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End-Stage Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Zemplar (paricalcitol injection)

Intervention Type DRUG

Calcijex

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Stage V Chronic Kidney Disease Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

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Global Medical Information 1-800-633-9110

Role: STUDY_DIRECTOR

Abbott

Locations

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Tuscaloosa Nephrology Associates

Tuscaloosa, Alabama, United States

Site Status

Gambro Healthcare - Inglewood

Inglewood, California, United States

Site Status

Gambro Healthcare - Los Angeles

Los Angeles, California, United States

Site Status

Apex Research of Riverside

Riverside, California, United States

Site Status

East Bay Nephrology Medical Group

San Pablo, California, United States

Site Status

Nephrology Educational Services and Research, Inc.

Tarzana, California, United States

Site Status

Lowry DaVita Dialysis Unit

Denver, Colorado, United States

Site Status

Stamford Nephrology

Stamford, Connecticut, United States

Site Status

Capital Dialysis Unit

Washington D.C., District of Columbia, United States

Site Status

Capitol Dialysis

Washington D.C., District of Columbia, United States

Site Status

Dupont III, P.C.

Washington D.C., District of Columbia, United States

Site Status

Capital Dialysis Northwest

Washington D.C., District of Columbia, United States

Site Status

Renal Associates of Boca Raton

Boca Raton, Florida, United States

Site Status

Associates in Nephrology

Fort Myers, Florida, United States

Site Status

Orlando Nephrology

Winter Garden, Florida, United States

Site Status

Nephrology Associates, P.C.

Augusta, Georgia, United States

Site Status

Nephrology Center of America - Augusta

Augusta, Georgia, United States

Site Status

Nephrology Center of America - South Augusta

Augusta, Georgia, United States

Site Status

Nephrology Center of America - Grovetown

Grovetown, Georgia, United States

Site Status

Nephrology Center of America - Vidalia

Vidalia, Georgia, United States

Site Status

Northwestern University - Division of Nephrology

Chicago, Illinois, United States

Site Status

Renal Care Group

Chicago, Illinois, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Evanston Northwestern Healthcare

Evanston, Illinois, United States

Site Status

Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Louisiana State University Health and Sciences Center

New Orleans, Louisiana, United States

Site Status

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Uptown Dialysis Center

New Orleans, Louisiana, United States

Site Status

Northwest Louisiana Nephrology

Shreveport, Louisiana, United States

Site Status

Paul Light, University of Maryland

Baltimore, Maryland, United States

Site Status

Gambro Healthcare - Whitesquare Dialysis Center

Baltimore, Maryland, United States

Site Status

Gambo Healthcare - JB Zachary Dialysis Center

Baltimore, Maryland, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Gambro Healthcare - Dundalk Dialysis Center

Dundalk, Maryland, United States

Site Status

Kidney Center of Frederick

Frederick, Maryland, United States

Site Status

Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Nephrology Foundation of Brooklyn

Brooklyn, New York, United States

Site Status

Brookdale University Hospital and Medical Center

Brooklyn, New York, United States

Site Status

Nephrology Foundation of Brooklyn

Brooklyn, New York, United States

Site Status

Gates Circle Dialysis

Buffalo, New York, United States

Site Status

Winthrop University Hospital

Mineola, New York, United States

Site Status

Chinatown Dialysis Center

New York, New York, United States

Site Status

Lower Manhatten Dialysis Center

New York, New York, United States

Site Status

Columbia University Dialysis Center

New York, New York, United States

Site Status

Orchard Park Dialysis

Orchard Park, New York, United States

Site Status

Suburban Dialysis Center

Williamsville, New York, United States

Site Status

The Rogosin Institute

Woodside, New York, United States

Site Status

Dialysis Clinic Inc

Cincinnati, Ohio, United States

Site Status

Northwest Renal Clinic, Inc.

Portland, Oregon, United States

Site Status

Doylestown Dialysis Center

Doylestown, Pennsylvania, United States

Site Status

Renal Care of Erie

Erie, Pennsylvania, United States

Site Status

Arlington Nephrology, PA

Arlington, Texas, United States

Site Status

UT Southwestern Medical School at Dallas, Nephrology Research Outpatient Clinic

Dallas, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Fletcher Allen Health Care

Burlington, Vermont, United States

Site Status

Jefferson Nephrology

Charlottesville, Virginia, United States

Site Status

Clinical Research Associates of Tidewater

Norfolk, Virginia, United States

Site Status

Gambro Healthcare

Richmond, Virginia, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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M02-516

Identifier Type: -

Identifier Source: org_study_id