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

Sponsoren

Hauptsponsor: Abbott

Quelle Abbott
Kurze Zusammenfassung

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.

Gesamtstatus Terminated
Anfangsdatum April 2003
Phase Phase 4
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Time to Death
Sekundäres Ergebnis
Messen Zeitfenster
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
Einschreibung 2200
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Zemplar (paricalcitol injection)

Interventionsart: Drug

Interventionsname: Calcijex

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 20 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Global Medical Information 1-800-633-9110 Study Director Abbott
Ort
Einrichtung:
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, District of Columbia, 20002-2132, United States
Capitol Dialysis | Washington, District of Columbia, 20002, United States
Dupont III, P.C. | Washington, District of Columbia, 20010, United States
Capital Dialysis Northwest | Washington, 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
Standort Länder

United States

Überprüfungsdatum

July 2006

Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Double

Quelle: ClinicalTrials.gov