Clinical trial NCT00062699: Evaluate the Survival Benefits of Zemplar Versus Calcijex in Subjects w/ Stage V Chronic Kidney Disease on Hemodialysis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: End-Stage Kidney Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-06-13
Enrollment: 2200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to Death
Secondary outcomes:
measure: Time to Death attributable to cardiovascular disease
measure: Number of hospitalizations for any cause
measure: Number of hospitalizations due to cardiovascular disease
measure: Number of days hospitalized for any cause
measure: Number of days hospitalized due to cardiovascular disease
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa Nephrology Associates
state: Alabama
city: Inglewood
country: United States
facility: Gambro Healthcare - Inglewood
state: California
city: Los Angeles
country: United States
facility: Gambro Healthcare - Los Angeles
state: California
city: Riverside
country: United States
facility: Apex Research of Riverside
state: California
city: San Pablo
country: United States
facility: East Bay Nephrology Medical Group
state: California
city: Tarzana
country: United States
facility: Nephrology Educational Services and Research, Inc.
state: California
city: Denver
country: United States
facility: Lowry DaVita Dialysis Unit
state: Colorado
city: Stamford
country: United States
facility: Stamford Nephrology
state: Connecticut
city: Washington
country: United States
facility: Capital Dialysis Unit
state: District of Columbia
city: Washington
country: United States
facility: Capitol Dialysis
state: District of Columbia
city: Washington
country: United States
facility: Dupont III, P.C.
state: District of Columbia
city: Washington
country: United States
facility: Capital Dialysis Northwest
state: District of Columbia
city: Boca Raton
country: United States
facility: Renal Associates of Boca Raton
state: Florida
city: Fort Myers
country: United States
facility: Associates in Nephrology
state: Florida
city: Winter Garden
country: United States
facility: Orlando Nephrology
state: Florida
city: Augusta
country: United States
facility: Nephrology Associates, P.C.
state: Georgia
city: Augusta
country: United States
facility: Nephrology Center of America - Augusta
state: Georgia
city: Augusta
country: United States
facility: Nephrology Center of America - South Augusta
state: Georgia
city: Grovetown
country: United States
facility: Nephrology Center of America - Grovetown
state: Georgia
city: Vidalia
country: United States
facility: Nephrology Center of America - Vidalia
state: Georgia
city: Chicago
country: United States
facility: Northwestern University - Division of Nephrology
state: Illinois
city: Chicago
country: United States
facility: Renal Care Group
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: New Orleans
country: United States
facility: Louisiana State University Health and Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Uptown Dialysis Center
state: Louisiana
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology
state: Louisiana
city: Baltimore
country: United States
facility: Paul Light, University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Gambro Healthcare - Whitesquare Dialysis Center
state: Maryland
city: Baltimore
country: United States
facility: Gambo Healthcare - JB Zachary Dialysis Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Dundalk
country: United States
facility: Gambro Healthcare - Dundalk Dialysis Center
state: Maryland
city: Frederick
country: United States
facility: Kidney Center of Frederick
state: Maryland
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Brooklyn
country: United States
facility: Nephrology Foundation of Brooklyn
state: New York
city: Brooklyn
country: United States
facility: Brookdale University Hospital and Medical Center
state: New York
city: Brooklyn
country: United States
facility: Nephrology Foundation of Brooklyn
state: New York
city: Buffalo
country: United States
facility: Gates Circle Dialysis
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: Chinatown Dialysis Center
state: New York
city: New York
country: United States
facility: Lower Manhatten Dialysis Center
state: New York
city: New York
country: United States
facility: Columbia University Dialysis Center
state: New York
city: Orchard Park
country: United States
facility: Orchard Park Dialysis
state: New York
city: Williamsville
country: United States
facility: Suburban Dialysis Center
state: New York
city: Woodside
country: United States
facility: The Rogosin Institute
state: New York
city: Cincinnati
country: United States
facility: Dialysis Clinic Inc
state: Ohio
city: Portland
country: United States
facility: Northwest Renal Clinic, Inc.
state: Oregon
city: Doylestown
country: United States
facility: Doylestown Dialysis Center
state: Pennsylvania
city: Erie
country: United States
facility: Renal Care of Erie
state: Pennsylvania
city: Arlington
country: United States
facility: Arlington Nephrology, PA
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical School at Dallas, Nephrology Research Outpatient Clinic
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Charlottesville
country: United States
facility: Jefferson Nephrology
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Richmond
country: United States
facility: Gambro Healthcare
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Abbott
name: Global Medical Information 1-800-633-9110
role: STUDY_DIRECTOR
References: