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

Primary Purpose

End-Stage Kidney Disease

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zemplar (paricalcitol injection)
Calcijex
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Kidney Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tuscaloosa Nephrology Associates
  • Gambro Healthcare - Inglewood
  • Gambro Healthcare - Los Angeles
  • Apex Research of Riverside
  • East Bay Nephrology Medical Group
  • Nephrology Educational Services and Research, Inc.
  • Lowry DaVita Dialysis Unit
  • Stamford Nephrology
  • Capital Dialysis Unit
  • Capitol Dialysis
  • Dupont III, P.C.
  • Capital Dialysis Northwest
  • Renal Associates of Boca Raton
  • Associates in Nephrology
  • Orlando Nephrology
  • Nephrology Associates, P.C.
  • Nephrology Center of America - Augusta
  • Nephrology Center of America - South Augusta
  • Nephrology Center of America - Grovetown
  • Nephrology Center of America - Vidalia
  • Northwestern University - Division of Nephrology
  • Renal Care Group
  • University of Chicago Medical Center
  • Evanston Northwestern Healthcare
  • Indiana University Hospital
  • Louisiana State University Health and Sciences Center
  • Tulane University Health Sciences Center
  • Uptown Dialysis Center
  • Northwest Louisiana Nephrology
  • Paul Light, University of Maryland
  • Gambro Healthcare - Whitesquare Dialysis Center
  • Gambo Healthcare - JB Zachary Dialysis Center
  • Johns Hopkins University
  • Gambro Healthcare - Dundalk Dialysis Center
  • Kidney Center of Frederick
  • Joslin Diabetes Center
  • Washington University School of Medicine
  • Nephrology Foundation of Brooklyn
  • Brookdale University Hospital and Medical Center
  • Nephrology Foundation of Brooklyn
  • Gates Circle Dialysis
  • Winthrop University Hospital
  • Chinatown Dialysis Center
  • Lower Manhatten Dialysis Center
  • Columbia University Dialysis Center
  • Orchard Park Dialysis
  • Suburban Dialysis Center
  • The Rogosin Institute
  • Dialysis Clinic Inc
  • Northwest Renal Clinic, Inc.
  • Doylestown Dialysis Center
  • Renal Care of Erie
  • Arlington Nephrology, PA
  • UT Southwestern Medical School at Dallas, Nephrology Research Outpatient Clinic
  • University of Texas Health Science Center at San Antonio
  • Fletcher Allen Health Care
  • Jefferson Nephrology
  • Clinical Research Associates of Tidewater
  • Gambro Healthcare
  • Virginia Commonwealth University

Outcomes

Primary Outcome Measures

Time to Death

Secondary Outcome Measures

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

Full Information

First Posted
June 11, 2003
Last Updated
July 31, 2006
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00062699
Brief Title
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

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Terminated
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zemplar (paricalcitol injection)
Intervention Type
Drug
Intervention Name(s)
Calcijex
Primary Outcome Measure Information:
Title
Time to Death
Secondary Outcome Measure Information:
Title
Time to Death attributable to cardiovascular disease
Title
Number of hospitalizations for any cause
Title
Number of hospitalizations due to cardiovascular disease
Title
Number of days hospitalized for any cause
Title
Number of days hospitalized due to cardiovascular disease

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Stage V Chronic Kidney Disease Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information 1-800-633-9110
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Tuscaloosa Nephrology Associates
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35476
Country
United States
Facility Name
Gambro Healthcare - Inglewood
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Gambro Healthcare - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
Apex Research of Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
East Bay Nephrology Medical Group
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
Nephrology Educational Services and Research, Inc.
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Lowry DaVita Dialysis Unit
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Stamford Nephrology
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Capital Dialysis Unit
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20002-2132
Country
United States
Facility Name
Capitol Dialysis
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20002
Country
United States
Facility Name
Dupont III, P.C.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Capital Dialysis Northwest
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Renal Associates of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33496
Country
United States
Facility Name
Associates in Nephrology
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33919
Country
United States
Facility Name
Orlando Nephrology
City
Winter Garden
State/Province
Florida
ZIP/Postal Code
34787
Country
United States
Facility Name
Nephrology Associates, P.C.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Nephrology Center of America - Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Nephrology Center of America - South Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30906
Country
United States
Facility Name
Nephrology Center of America - Grovetown
City
Grovetown
State/Province
Georgia
ZIP/Postal Code
30813
Country
United States
Facility Name
Nephrology Center of America - Vidalia
City
Vidalia
State/Province
Georgia
ZIP/Postal Code
30474
Country
United States
Facility Name
Northwestern University - Division of Nephrology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Renal Care Group
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60617
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Louisiana State University Health and Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Uptown Dialysis Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Northwest Louisiana Nephrology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Paul Light, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Gambro Healthcare - Whitesquare Dialysis Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21221
Country
United States
Facility Name
Gambo Healthcare - JB Zachary Dialysis Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212224
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212224
Country
United States
Facility Name
Gambro Healthcare - Dundalk Dialysis Center
City
Dundalk
State/Province
Maryland
ZIP/Postal Code
21222
Country
United States
Facility Name
Kidney Center of Frederick
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nephrology Foundation of Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11207
Country
United States
Facility Name
Brookdale University Hospital and Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
Nephrology Foundation of Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11238
Country
United States
Facility Name
Gates Circle Dialysis
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Chinatown Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Facility Name
Lower Manhatten Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Orchard Park Dialysis
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
Suburban Dialysis Center
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
The Rogosin Institute
City
Woodside
State/Province
New York
ZIP/Postal Code
11377
Country
United States
Facility Name
Dialysis Clinic Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
Northwest Renal Clinic, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Doylestown Dialysis Center
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Renal Care of Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16502
Country
United States
Facility Name
Arlington Nephrology, PA
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
UT Southwestern Medical School at Dallas, Nephrology Research Outpatient Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8856
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Jefferson Nephrology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Gambro Healthcare
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23223
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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