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

July 31, 2006 updated by: Abbott

A Phase IV, Prospective, Randomized, Active-Controlled, Double-Blind, Double-Dummy, Multi-Center Study to Evaluate the Survival Benefits of Zemplar Relative to Calcijex in Subjects With Stage V Chronic Kidney Disease on Hemodialysis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

2200

Phase

  • Phase 4

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
    • Alabama
      • Tuscaloosa, Alabama, United States, 35476
        • Tuscaloosa Nephrology Associates
    • California
      • Inglewood, California, United States, 90301
        • Gambro Healthcare - Inglewood
      • Los Angeles, California, United States, 90059
        • Gambro Healthcare - Los Angeles
      • Riverside, California, United States, 92501
        • Apex Research of Riverside
      • San Pablo, California, United States, 94806
        • East Bay Nephrology Medical Group
      • Tarzana, California, United States, 91356
        • Nephrology Educational Services and Research, Inc.
    • Colorado
      • Denver, Colorado, United States, 80230
        • Lowry DaVita Dialysis Unit
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • Stamford Nephrology
    • District of Columbia
      • Washington, District of Columbia, United States, 20002
        • Capitol Dialysis
      • Washington, District of Columbia, United States, 20002-2132
        • Capital Dialysis Unit
      • Washington, District of Columbia, United States, 20010
        • Dupont III, P.C.
      • Washington, District of Columbia, United States, 20016
        • Capital Dialysis Northwest
    • Florida
      • Boca Raton, Florida, United States, 33496
        • Renal Associates of Boca Raton
      • Fort Myers, Florida, United States, 33919
        • Associates in Nephrology
      • Winter Garden, Florida, United States, 34787
        • Orlando Nephrology
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Nephrology Associates, P.C.
      • Augusta, Georgia, United States, 30901
        • Nephrology Center of America - Augusta
      • Augusta, Georgia, United States, 30906
        • Nephrology Center of America - South Augusta
      • Grovetown, Georgia, United States, 30813
        • Nephrology Center of America - Grovetown
      • Vidalia, Georgia, United States, 30474
        • Nephrology Center of America - Vidalia
    • Illinois
      • Chicago, Illinois, United States, 60617
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University - Division of Nephrology
      • Chicago, Illinois, United States, 60611
        • Renal Care Group
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Healthcare
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health and Sciences Center
      • New Orleans, Louisiana, United States, 70115
        • Uptown Dialysis Center
      • Shreveport, Louisiana, United States, 71101
        • Northwest Louisiana Nephrology
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Paul Light, University of Maryland
      • Baltimore, Maryland, United States, 21221
        • Gambro Healthcare - Whitesquare Dialysis Center
      • Baltimore, Maryland, United States, 212224
        • Gambo Healthcare - JB Zachary Dialysis Center
      • Baltimore, Maryland, United States, 212224
        • Johns Hopkins University
      • Dundalk, Maryland, United States, 21222
        • Gambro Healthcare - Dundalk Dialysis Center
      • Frederick, Maryland, United States, 21702
        • Kidney Center of Frederick
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • Brooklyn, New York, United States, 11212
        • Brookdale University Hospital and Medical Center
      • Brooklyn, New York, United States, 11207
        • Nephrology Foundation of Brooklyn
      • Brooklyn, New York, United States, 11238
        • Nephrology Foundation of Brooklyn
      • Buffalo, New York, United States, 14209
        • Gates Circle Dialysis
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New York, New York, United States, 10013
        • Chinatown Dialysis Center
      • New York, New York, United States, 10016
        • Lower Manhatten Dialysis Center
      • New York, New York, United States, 10032
        • Columbia University Dialysis Center
      • Orchard Park, New York, United States, 14127
        • Orchard Park Dialysis
      • Williamsville, New York, United States, 14221
        • Suburban Dialysis Center
      • Woodside, New York, United States, 11377
        • The Rogosin Institute
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • Dialysis Clinic Inc
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Renal Clinic, Inc.
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Dialysis Center
      • Erie, Pennsylvania, United States, 16502
        • Renal Care of Erie
    • Texas
      • Arlington, Texas, United States, 76015
        • Arlington Nephrology, PA
      • Dallas, Texas, United States, 75390-8856
        • UT Southwestern Medical School at Dallas, Nephrology Research Outpatient Clinic
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Jefferson Nephrology
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23223
        • Gambro Healthcare

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to Death

Secondary Outcome Measures

Outcome Measure
Time to Death attributable to cardiovascular disease
Number of hospitalizations for any cause
Number of hospitalizations due to cardiovascular disease
Number of days hospitalized for any cause
Number of days hospitalized due to cardiovascular disease

Collaborators and Investigators

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

Sponsor

Abbott

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

April 1, 2003

Study Registration Dates

First Submitted

June 11, 2003

First Submitted That Met QC Criteria

June 12, 2003

First Posted (Estimate)

June 13, 2003

Study Record Updates

Last Update Posted (Estimate)

August 2, 2006

Last Update Submitted That Met QC Criteria

July 31, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-516

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.

Clinical Trials on End-Stage Kidney Disease

Clinical Trials on Calcijex

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe