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
Evaluate the Survival Benefits of Zemplar Versus Calcijex in Subjects w/ Stage V Chronic Kidney Disease on Hemodialysis
Sponsors
Source
Abbott
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.
Overall Status
Terminated
Start Date
2003-04-01
Completion Date
N/A
Primary Completion Date
N/A
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
|
Time to Death |
Secondary Outcome
Measure |
|
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 |
Enrollment
2200
Condition
Intervention
Eligibility
Criteria
Stage V Chronic Kidney Disease Patients on Hemodialysis requiring treatment for secondary
hyperparathyroidism with vitamin D therapy
Gender
All
Minimum Age
20 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Global Medical Information 1-800-633-9110 |
Study Director |
Abbott |
Location
Facility |
|
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 |
Location Countries
Country
United States
Verification Date
2006-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Condition Browse
Intervention Browse
Mesh Term
Calcitriol
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double
Study First Submitted
June 11, 2003
Study First Submitted Qc
June 12, 2003
Study First Posted
June 13, 2003
Last Update Submitted
July 31, 2006
Last Update Submitted Qc
July 31, 2006
Last Update Posted
August 2, 2006
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.