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

End-Stage Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00062699
• Other study ID #: M02-516
• Status: Terminated
• Phase: Phase 4
• First received: June 11, 2003
• Last updated: July 31, 2006
• Start date: April 2003

Study information

• Verified date: July 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• Zemplar (paricalcitol injection)

• Calcijex

Locations

Country	Name	City	State
United States	Arlington Nephrology, PA	Arlington	Texas
United States	Nephrology Associates, P.C.	Augusta	Georgia
United States	Nephrology Center of America - Augusta	Augusta	Georgia
United States	Nephrology Center of America - South Augusta	Augusta	Georgia
United States	Gambo Healthcare - JB Zachary Dialysis Center	Baltimore	Maryland
United States	Gambro Healthcare - Whitesquare Dialysis Center	Baltimore	Maryland
United States	Johns Hopkins University	Baltimore	Maryland
United States	Paul Light, University of Maryland	Baltimore	Maryland
United States	Renal Associates of Boca Raton	Boca Raton	Florida
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	Brookdale University Hospital and Medical Center	Brooklyn	New York
United States	Nephrology Foundation of Brooklyn	Brooklyn	New York
United States	Nephrology Foundation of Brooklyn	Brooklyn	New York
United States	Gates Circle Dialysis	Buffalo	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Jefferson Nephrology	Charlottesville	Virginia
United States	Northwestern University - Division of Nephrology	Chicago	Illinois
United States	Renal Care Group	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Dialysis Clinic Inc	Cincinnati	Ohio
United States	UT Southwestern Medical School at Dallas, Nephrology Research Outpatient Clinic	Dallas	Texas
United States	Lowry DaVita Dialysis Unit	Denver	Colorado
United States	Doylestown Dialysis Center	Doylestown	Pennsylvania
United States	Gambro Healthcare - Dundalk Dialysis Center	Dundalk	Maryland
United States	Renal Care of Erie	Erie	Pennsylvania
United States	Evanston Northwestern Healthcare	Evanston	Illinois
United States	Associates in Nephrology	Fort Myers	Florida
United States	Kidney Center of Frederick	Frederick	Maryland
United States	Nephrology Center of America - Grovetown	Grovetown	Georgia
United States	Indiana University Hospital	Indianapolis	Indiana
United States	Gambro Healthcare - Inglewood	Inglewood	California
United States	Gambro Healthcare - Los Angeles	Los Angeles	California
United States	Winthrop University Hospital	Mineola	New York
United States	Louisiana State University Health and Sciences Center	New Orleans	Louisiana
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Uptown Dialysis Center	New Orleans	Louisiana
United States	Chinatown Dialysis Center	New York	New York
United States	Columbia University Dialysis Center	New York	New York
United States	Lower Manhatten Dialysis Center	New York	New York
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Orchard Park Dialysis	Orchard Park	New York
United States	Northwest Renal Clinic, Inc.	Portland	Oregon
United States	Gambro Healthcare	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Apex Research of Riverside	Riverside	California
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	East Bay Nephrology Medical Group	San Pablo	California
United States	Northwest Louisiana Nephrology	Shreveport	Louisiana
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Stamford Nephrology	Stamford	Connecticut
United States	Nephrology Educational Services and Research, Inc.	Tarzana	California
United States	Tuscaloosa Nephrology Associates	Tuscaloosa	Alabama
United States	Nephrology Center of America - Vidalia	Vidalia	Georgia
United States	Capital Dialysis Northwest	Washington	District of Columbia
United States	Capital Dialysis Unit	Washington	District of Columbia
United States	Capitol Dialysis	Washington	District of Columbia
United States	Dupont III, P.C.	Washington	District of Columbia
United States	Suburban Dialysis Center	Williamsville	New York
United States	Orlando Nephrology	Winter Garden	Florida
United States	The Rogosin Institute	Woodside	New York

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Death
Secondary	Time to Death attributable to cardiovascular disease
Secondary	Number of hospitalizations for any cause
Secondary	Number of hospitalizations due to cardiovascular disease
Secondary	Number of days hospitalized for any cause
Secondary	Number of days hospitalized due to cardiovascular disease