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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00062699 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
End-Stage Kidney Disease |
Drug: Zemplar (paricalcitol injection) Drug: Calcijex |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 2200 |
| Study Start Date: | April 2003 |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Stage V Chronic Kidney Disease Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Tuscaloosa Nephrology Associates | |
| Tuscaloosa, Alabama, United States, 35476 | |
| United States, California | |
| Apex Research of Riverside | |
| Riverside, California, United States, 92501 | |
| Nephrology Educational Services and Research, Inc. | |
| Tarzana, California, United States, 91356 | |
| East Bay Nephrology Medical Group | |
| San Pablo, California, United States, 94806 | |
| Gambro Healthcare - Los Angeles | |
| Los Angeles, California, United States, 90059 | |
| Gambro Healthcare - Inglewood | |
| Inglewood, California, United States, 90301 | |
| United States, Colorado | |
| Lowry DaVita Dialysis Unit | |
| Denver, Colorado, United States, 80230 | |
| United States, Connecticut | |
| Stamford Nephrology | |
| Stamford, Connecticut, United States, 06902 | |
| United States, District of Columbia | |
| Dupont III, P.C. | |
| Washington, District of Columbia, United States, 20010 | |
| Capitol Dialysis | |
| Washington, District of Columbia, United States, 20002 | |
| Capital Dialysis Northwest | |
| Washington, District of Columbia, United States, 20016 | |
| Capital Dialysis Unit | |
| Washington, District of Columbia, United States, 20002-2132 | |
| United States, Florida | |
| Renal Associates of Boca Raton | |
| Boca Raton, Florida, United States, 33496 | |
| Associates in Nephrology | |
| Fort Myers, Florida, United States, 33919 | |
| Orlando Nephrology | |
| Winter Garden, Florida, United States, 34787 | |
| United States, Georgia | |
| Nephrology Associates, P.C. | |
| Augusta, Georgia, United States, 30901 | |
| Nephrology Center of America - South Augusta | |
| Augusta, Georgia, United States, 30906 | |
| Nephrology Center of America - Augusta | |
| Augusta, Georgia, United States, 30901 | |
| Nephrology Center of America - Grovetown | |
| Grovetown, Georgia, United States, 30813 | |
| Nephrology Center of America - Vidalia | |
| Vidalia, Georgia, United States, 30474 | |
| United States, Illinois | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60617 | |
| Evanston Northwestern Healthcare | |
| Evanston, Illinois, United States, 60201 | |
| Northwestern University - Division of Nephrology | |
| Chicago, Illinois, United States, 60611 | |
| Renal Care Group | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana University Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Uptown Dialysis Center | |
| New Orleans, Louisiana, United States, 70115 | |
| Tulane University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Louisiana State University Health and Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Northwest Louisiana Nephrology | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Maryland | |
| Kidney Center of Frederick | |
| Frederick, Maryland, United States, 21702 | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 212224 | |
| Gambo Healthcare - JB Zachary Dialysis Center | |
| Baltimore, Maryland, United States, 212224 | |
| Gambro Healthcare - Whitesquare Dialysis Center | |
| Baltimore, Maryland, United States, 21221 | |
| Gambro Healthcare - Dundalk Dialysis Center | |
| Dundalk, Maryland, United States, 21222 | |
| Paul Light, University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Joslin Diabetes Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Nephrology Foundation of Brooklyn | |
| Brooklyn, New York, United States, 11238 | |
| Suburban Dialysis Center | |
| Williamsville, New York, United States, 14221 | |
| Nephrology Foundation of Brooklyn | |
| Brooklyn, New York, United States, 11207 | |
| The Rogosin Institute | |
| Woodside, New York, United States, 11377 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| Gates Circle Dialysis | |
| Buffalo, New York, United States, 14209 | |
| Orchard Park Dialysis | |
| Orchard Park, New York, United States, 14127 | |
| Brookdale University Hospital and Medical Center | |
| Brooklyn, New York, United States, 11212 | |
| Lower Manhatten Dialysis Center | |
| New York, New York, United States, 10016 | |
| Chinatown Dialysis Center | |
| New York, New York, United States, 10013 | |
| Columbia University Dialysis Center | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Dialysis Clinic Inc | |
| Cincinnati, Ohio, United States, 45206 | |
| United States, Oregon | |
| Northwest Renal Clinic, Inc. | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Doylestown Dialysis Center | |
| Doylestown, Pennsylvania, United States, 18901 | |
| Renal Care of Erie | |
| Erie, Pennsylvania, United States, 16502 | |
| United States, Texas | |
| Arlington Nephrology, PA | |
| Arlington, Texas, United States, 76015 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| UT Southwestern Medical School at Dallas, Nephrology Research Outpatient Clinic | |
| Dallas, Texas, United States, 75390-8856 | |
| United States, Vermont | |
| Fletcher Allen Health Care | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Jefferson Nephrology | |
| Charlottesville, Virginia, United States, 22902 | |
| Gambro Healthcare | |
| Richmond, Virginia, United States, 23223 | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
| Clinical Research Associates of Tidewater | |
| Norfolk, Virginia, United States, 23507 | |
| Study Director: | Global Medical Information 1-800-633-9110 | Abbott |
More Information
| Study ID Numbers: | M02-516 |
| Study First Received: | June 11, 2003 |
| Last Updated: | July 31, 2006 |
| ClinicalTrials.gov Identifier: | NCT00062699 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Renal Insufficiency Molecular Mechanisms of Pharmacological Action Growth Substances Calcium Channel Agonists Physiological Effects of Drugs Kidney Failure, Chronic Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions Calcitriol |
Membrane Transport Modulators Urologic Diseases Renal Insufficiency, Chronic Therapeutic Uses Vitamins Vasoconstrictor Agents Kidney Diseases Micronutrients Kidney Failure |
