End-Stage Kidney DiseasePhase 4NCT00062699
Evaluate the Survival Benefits of Zemplar Versus Calcijex in Subjects w/ Stage V Chronic Kidney Disease on Hemodialysis
A Phase 4 study testing Zemplar (paricalcitol injection) and Calcijex in people with End-Stage Kidney Disease, run by Abbott at 60 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End-Stage Kidney Disease
- What is being tested?
- Zemplar (paricalcitol injection) and Calcijex
- Type of treatment
- Injection or infusion
- How many people
- 2,200 participants
- Where
- 60 sitesUnited States
- Study dates
- Apr 2003to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Stage V Chronic Kidney Disease Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United States60 sites
Arlington Nephrology, PA
Arlington, Texas, 76015
Nephrology Associates, P.C.
Augusta, Georgia, 30901
Nephrology Center of America - Augusta
Augusta, Georgia, 30901
Nephrology Center of America - South Augusta
Augusta, Georgia, 30906
Paul Light, University of Maryland
Baltimore, Maryland, 21201
Gambro Healthcare - Whitesquare Dialysis Center
Baltimore, Maryland, 21221
Gambo Healthcare - JB Zachary Dialysis Center
Baltimore, Maryland, 212224
Johns Hopkins University
Baltimore, Maryland, 212224
Renal Associates of Boca Raton
Boca Raton, Florida, 33496
Joslin Diabetes Center
Boston, Massachusetts, 02215
Nephrology Foundation of Brooklyn
Brooklyn, New York, 11207
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
Nephrology Foundation of Brooklyn
Brooklyn, New York, 11238
Gates Circle Dialysis
Buffalo, New York, 14209
Fletcher Allen Health Care
Burlington, Vermont, 05401
Jefferson Nephrology
Charlottesville, Virginia, 22902
Northwestern University - Division of Nephrology
Chicago, Illinois, 60611
Renal Care Group
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60617
Dialysis Clinic Inc
Cincinnati, Ohio, 45206
UT Southwestern Medical School at Dallas, Nephrology Research Outpatient Clinic
Dallas, Texas, 75390-8856
Lowry DaVita Dialysis Unit
Denver, Colorado, 80230
Doylestown Dialysis Center
Doylestown, Pennsylvania, 18901
Gambro Healthcare - Dundalk Dialysis Center
Dundalk, Maryland, 21222
Renal Care of Erie
Erie, Pennsylvania, 16502
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
Associates in Nephrology
Fort Myers, Florida, 33919
Kidney Center of Frederick
Frederick, Maryland, 21702
Nephrology Center of America - Grovetown
Grovetown, Georgia, 30813
Indiana University Hospital
Indianapolis, Indiana, 46202
Gambro Healthcare - Inglewood
Inglewood, California, 90301
Gambro Healthcare - Los Angeles
Los Angeles, California, 90059
Winthrop University Hospital
Mineola, New York, 11501
Louisiana State University Health and Sciences Center
New Orleans, Louisiana, 70112
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Uptown Dialysis Center
New Orleans, Louisiana, 70115
Chinatown Dialysis Center
New York, New York, 10013
Lower Manhatten Dialysis Center
New York, New York, 10016
Columbia University Dialysis Center
New York, New York, 10032
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
Orchard Park Dialysis
Orchard Park, New York, 14127
Northwest Renal Clinic, Inc.
Portland, Oregon, 97210
Gambro Healthcare
Richmond, Virginia, 23223
Virginia Commonwealth University
Richmond, Virginia, 23298
Apex Research of Riverside
Riverside, California, 92501
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
East Bay Nephrology Medical Group
San Pablo, California, 94806
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101
Washington University School of Medicine
St Louis, Missouri, 63110
Stamford Nephrology
Stamford, Connecticut, 06902
Nephrology Educational Services and Research, Inc.
Tarzana, California, 91356
Tuscaloosa Nephrology Associates
Tuscaloosa, Alabama, 35476
Nephrology Center of America - Vidalia
Vidalia, Georgia, 30474
Capital Dialysis Unit
Washington D.C., District of Columbia, 20002-2132
Capitol Dialysis
Washington D.C., District of Columbia, 20002
Dupont III, P.C.
Washington D.C., District of Columbia, 20010
Capital Dialysis Northwest
Washington D.C., District of Columbia, 20016
Suburban Dialysis Center
Williamsville, New York, 14221
Orlando Nephrology
Winter Garden, Florida, 34787
The Rogosin Institute
Woodside, New York, 11377
About this 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
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.
- Conditions
- End-Stage Kidney Disease
- Being tested
- Zemplar (paricalcitol injection), Calcijex
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zemplar (paricalcitol injection)Drug
CalcijexDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Death
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2003 (estimated)
- Study startApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 2,200 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information 1-800-633-9110, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062699
- Sponsor's protocol ID
- M02-516
- Status last verified
- Jul 2006
- First submitted
- 11 Jun 2003
- Last updated
- 2 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00062699
- Acronym / sponsor ID
- M02-516
- Conditions
- End-Stage Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2,200 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- First posted
- 13 Jun 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zemplar (paricalcitol injection) | Drug | – |
| Calcijex | Drug | – |
Primary outcome
Time to Death
5 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Medical Information 1-800-633-9110 study director
Abbott
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zemplar (paricalcitol injection) and Calcijex in people with End-Stage Kidney Disease, run by Abbott at 60 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Death. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2006.