Evaluate the Survival Benefits of Zemplar Versus Calcijex in Subjects w/ Stage V Chronic Kidney Disease on Hemodialysis
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
1 other identifier
interventional
2,200
1 country
60
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 11, 2003
CompletedFirst Posted
Study publicly available on registry
June 13, 2003
CompletedAugust 2, 2006
July 1, 2006
June 11, 2003
July 31, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Death
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Abbottlead
Study Sites (60)
Tuscaloosa Nephrology Associates
Tuscaloosa, Alabama, 35476, United States
Gambro Healthcare - Inglewood
Inglewood, California, 90301, United States
Gambro Healthcare - Los Angeles
Los Angeles, California, 90059, United States
Apex Research of Riverside
Riverside, California, 92501, United States
East Bay Nephrology Medical Group
San Pablo, California, 94806, United States
Nephrology Educational Services and Research, Inc.
Tarzana, California, 91356, United States
Lowry DaVita Dialysis Unit
Denver, Colorado, 80230, United States
Stamford Nephrology
Stamford, Connecticut, 06902, United States
Capital Dialysis Unit
Washington D.C., District of Columbia, 20002-2132, United States
Capitol Dialysis
Washington D.C., District of Columbia, 20002, United States
Dupont III, P.C.
Washington D.C., District of Columbia, 20010, United States
Capital Dialysis Northwest
Washington D.C., District of Columbia, 20016, United States
Renal Associates of Boca Raton
Boca Raton, Florida, 33496, United States
Associates in Nephrology
Fort Myers, Florida, 33919, United States
Orlando Nephrology
Winter Garden, Florida, 34787, United States
Nephrology Associates, P.C.
Augusta, Georgia, 30901, United States
Nephrology Center of America - Augusta
Augusta, Georgia, 30901, United States
Nephrology Center of America - South Augusta
Augusta, Georgia, 30906, United States
Nephrology Center of America - Grovetown
Grovetown, Georgia, 30813, United States
Nephrology Center of America - Vidalia
Vidalia, Georgia, 30474, United States
Northwestern University - Division of Nephrology
Chicago, Illinois, 60611, United States
Renal Care Group
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60617, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
Louisiana State University Health and Sciences Center
New Orleans, Louisiana, 70112, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Uptown Dialysis Center
New Orleans, Louisiana, 70115, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101, United States
Paul Light, University of Maryland
Baltimore, Maryland, 21201, United States
Gambro Healthcare - Whitesquare Dialysis Center
Baltimore, Maryland, 21221, United States
Gambo Healthcare - JB Zachary Dialysis Center
Baltimore, Maryland, 212224, United States
Johns Hopkins University
Baltimore, Maryland, 212224, United States
Gambro Healthcare - Dundalk Dialysis Center
Dundalk, Maryland, 21222, United States
Kidney Center of Frederick
Frederick, Maryland, 21702, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Nephrology Foundation of Brooklyn
Brooklyn, New York, 11207, United States
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212, United States
Nephrology Foundation of Brooklyn
Brooklyn, New York, 11238, United States
Gates Circle Dialysis
Buffalo, New York, 14209, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Chinatown Dialysis Center
New York, New York, 10013, United States
Lower Manhatten Dialysis Center
New York, New York, 10016, United States
Columbia University Dialysis Center
New York, New York, 10032, United States
Orchard Park Dialysis
Orchard Park, New York, 14127, United States
Suburban Dialysis Center
Williamsville, New York, 14221, United States
The Rogosin Institute
Woodside, New York, 11377, United States
Dialysis Clinic Inc
Cincinnati, Ohio, 45206, United States
Northwest Renal Clinic, Inc.
Portland, Oregon, 97210, United States
Doylestown Dialysis Center
Doylestown, Pennsylvania, 18901, United States
Renal Care of Erie
Erie, Pennsylvania, 16502, United States
Arlington Nephrology, PA
Arlington, Texas, 76015, United States
UT Southwestern Medical School at Dallas, Nephrology Research Outpatient Clinic
Dallas, Texas, 75390-8856, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Jefferson Nephrology
Charlottesville, Virginia, 22902, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Gambro Healthcare
Richmond, Virginia, 23223, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Medical Information 1-800-633-9110
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 11, 2003
First Posted
June 13, 2003
Study Start
April 1, 2003
Last Updated
August 2, 2006
Record last verified: 2006-07