Chronic Kidney DiseasePhase 4NCT00324571
Dialysis Clinical Outcomes Revisited (DCOR) Trial
A Phase 4 study testing Sevelamer hydrochloride and Calcium-based phosphate binder in people with Chronic Kidney Disease, run by Genzyme, a Sanofi Company at 73 sites in 2 countries.
Trial summary
This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients. Informed consent will be obtained and the inclusion/exclusion criteria reviewed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Sevelamer hydrochloride and Calcium-based phosphate binder
- How many people
- 2,000 participants
- Where
- 73 sitesin 2 countries
- Study dates
- Mar 2001to Feb 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients must be 18 years of age or older,
- on dialysis for more than 3 months,
- require phosphate binder therapy,
- have Medicare as their primary insurance.
Who cannot join
- dysphagia,
- swallowing disorders,
- severe gastrointestinal motility disorders,
- bowel obstruction.
Trial locations and contacts
73 sites in 2 countries.
73 sites in 2 countries
United States72 sites
Gambro Healthcare-Aiken
Aiken, South Carolina
FMC of Bethlehem
Allentown, Pennsylvania
Gambro Healthcare-Americus
Americus, Georgia
Mountain Kidney Associates, P.A.
Asheville, North Carolina
nTouch Research
Atlanta, Georgia
MacNeal Renal Lifeline Services
Berwyn, Illinois
BMA of Washington
Bethesda, Maryland
Nephrology Associates, P.C.
Bridgeport, Connecticut
Associates in Nephrology, P.C.
Brockton, Massachusetts
Gambro Healthcare - Charlottesville
Charlottesville, Virginia, 22902
Kidney and Hypertension Center
Cincinnati, Ohio, 45220
Nephrology Associates, P.C.
Columbus, Mississippi, 39705
Ohio State University College of Pharmacy
Columbus, Ohio
InterAmerican Dialysis
Coral Gables, Florida
DaVita Crystal River Dialysis
Crystal River, Florida
Dallas Nephrology Associates
Dallas, Texas
Lowry Dialysis Center
Denver, Colorado
Gambro Healthcare-Douglas
Douglas, Georgia
Gambro Healthcare-Douglasville
Douglasville, Georgia
Dublin Nephrology
Dublin, Georgia
Gambro Healthcare
El Cerrito, California
Palomar Medical Group
Escondido, California
Southwest Nephrology
Evergreen Park, Illinois
Clinical Research and Consulting Center, LLC
Fairfax, Virginia
Gambro Healthcare-Frederick
Frederick, Maryland
Gambro Healthcare-Gadsden
Gadsden, Alabama
Fresenius Medical Care
Greensburg, Pennsylvania
Gambro Healthcare-Hartford
Hartford, Connecticut
Nephrology, Dialysis and Transplant Association
Houston, Texas
West Houston Dialysis
Houston, Texas
nTouch Research
Huntsville, Alabama
University of Missouri-Kansas City
Kansas City, Missouri
Hypertension and Kidney Specialists
Lancaster, Pennsylvania
Nephrology and Endocrine Associates
Las Vegas, Nevada
DaVita Lewistown Dialysis Center
Lewistown, Pennsylvania
Gambro Healthcare-Los Angeles
Los Angeles, California
Georgia Kidney Associates, Inc.
Marietta, Georgia
Midsouth Nephrology Consultants
Memphis, Tennessee
Gambro Healthcare-Miami
Miami, Florida
Miami Kidney Group
Miami, Florida
DaVita Clinical Research
Minneapolis, Minnesota
Nephrology Associates
New Britain, Connecticut
Clinical Research of Tidewater
Norfolk, Virginia, 23507
Horizon Healthcare Associates
Olympia Fields, Illinois
Pensacola Nephrology, P.A.
Pensacola, Florida
Renal Care Associates, S.C.
Peoria, Illinois
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
P.C. & Associates
Philadelphia, Pennsylvania
Gambro Healthcare-Plantation
Plantation, Florida
nTouch Research
Raleigh, North Carolina
Wake Nephrology/Wake Dialysis Clinic
Raleigh, North Carolina
Virginia Commonwealth University, Division of Nephrology
Richmond, Virginia, 23298
Gambro Healthcare-Rome
Rome, Georgia
San Antonio Kidney Disease Center
San Antonio, Texas
Balboa Nephrology Medical Group
San Diego, California
Gambro Healthcare-Savannah
Savannah, Georgia
Northwest Louisiana Nephrology, LLC.
Shreveport, Louisiana
Gambro Healthcare-Springfield Central
Springfield, Illinois
Lincolnland Dialysis
Springfield, Illinois
Western New England Renal and Transplant Associates, Inc.
Springfield, Massachusetts
DaVita Crystal City Dialysis
St Louis, Missouri
America Dialysis
St. Petersburg, Florida
Genesis Clinical Research Corp
Tampa, Florida
Nephrology Educational Services and Research
Tarzana, California
Bronx Westchester Medical Group
The Bronx, New York
Kidney Health Institute, LLC
Tucson, Arizona
Nephrology Specialists, PC.
Valparaiso, Indiana
Vancouver Clinic Inc., P.S.
Vancouver, Washington
Wichita Dialysis Center East
Wichita, Kansas
Wichita Nephrology
Wichita, Kansas
Nesbitt College of Pharmacy and Nursing Department of Pharmacy Practice
Wilkes-Barre, Pennsylvania
Gambro Healthcare-Wilson
Wilson, North Carolina
About this study
Official title: A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients
This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients. Informed consent will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be randomized to receive either Renagel or a calcium-based binder.
Starting from the randomization date, mortality data including survival, death date and cause of death (vital status information) and morbidity data including hospitalization date will be recorded for all patients. These data will be collected until the end of the study (December 31, 2004, ± 2 weeks). Patients completing or terminating from the study will return to the phosphate binder prescribed by their usual healthcare provider.
- Conditions
- Chronic Kidney Disease
- Being tested
- Sevelamer hydrochloride, Calcium-based phosphate binder
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevelamer hydrochlorideDrug
Calcium-based phosphate binderDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy will be evaluated based on a comparison of the association of Renagel use versus calcium-based phosphate binder use on all-cause mortality, cause-specific mortality (cardiovascular, infection, other), and all-cause hospitalization.
Safety will be assessed based on an evaluation of related serious adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study startMar 2001
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- None (open label)
- Enrolment
- 2,000 participants
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324571
- Sponsor's protocol ID
- GTC-68-401
- Status last verified
- Mar 2015
- First submitted
- 9 May 2006
- Last updated
- 18 Mar 2015
- Results posted
- No
Publications
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PubMed 40576086
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00324571
- Acronym / sponsor ID
- GTC-68-401
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Study completion
- Feb 2006
- First posted
- 11 May 2006 (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.
This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients. Informed consent will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be randomized to receive either Renagel or a calcium-based binder.
Starting from the randomization date, mortality data including survival, death date and cause of death (vital status information) and morbidity data including hospitalization date will be recorded for all patients. These data will be collected until the end of the study (December 31, 2004, ± 2 weeks). Patients completing or terminating from the study will return to the phosphate binder prescribed by their usual healthcare provider.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients must be 18 years of age or older,
- on dialysis for more than 3 months,
- require phosphate binder therapy,
- have Medicare as their primary insurance.
Key exclusion criteria (4 listed)
- dysphagia,
- swallowing disorders,
- severe gastrointestinal motility disorders,
- bowel obstruction.
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 |
|---|---|---|
| Sevelamer hydrochloride | Drug | – |
| Calcium-based phosphate binder | Drug | – |
Primary outcome
Efficacy will be evaluated based on a comparison of the association of Renagel use versus calcium-based phosphate binder use on all-cause mortality, cause-specific mortality (cardiovascular, infection, other), and all-cause hospitalization.
Safety will be assessed based on an evaluation of related serious adverse events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Derived from this study: PubMed 40576086Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
73 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevelamer hydrochloride and Calcium-based phosphate binder in people with Chronic Kidney Disease, run by Genzyme, a Sanofi Company at 73 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in United States, Puerto Rico. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy will be evaluated based on a comparison of the association of Renagel use versus calcium-based phosphate binder use on all-cause mortality, cause-specific mortality (cardiovascular, infection, other), and all-cause hospitalization.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00324571, which also lists 1 linked publication.
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 18 Mar 2015.