Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
NCT ID: NCT00123461
Last Updated: 2015-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2005-07-31
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Hectorol (doxercalciferol capsules), 0.5mcg
Eligibility Criteria
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Inclusion Criteria
* Serum 25-hydroxyvitamin D level greater than or equal to 30 ng/mL
* CKD Stage 3 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 30-59 mL/min or CKD Stage 4 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 15-29 mL/min
Exclusion Criteria
* Serum P \> 4.6 mg/dL
* Abnormal liver functions
* Anticipated requirement for maintenance hemodialysis
* Use of active vitamin D sterol therapy
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Genzyme Corporation
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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AKDHC Medical Research Services
Phoenix, Arizona, United States
UCLA Diabetes Reseach Center
Alhambra, California, United States
Apex Research of Riverside
Riverside, California, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
Discovery Medical Research Group
Ocala, Florida, United States
Nephrology Associates
Palm Beach Gardens, Florida, United States
Georgia Kidney Associates, Inc.
Marietta, Georgia, United States
Michigan Kidney Consultants, P.C.
Pontiac, Michigan, United States
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Wake Nephrology Associates, PA
Raleigh, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Altru Health System Research Center
Grand Forks, North Dakota, United States
DaVita Lewiston Dialysis Center
Lewiston, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Instituto Renal del Este
Caguas, , Puerto Rico
Jose Cangiano, MD
San Juan, , Puerto Rico
Countries
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Related Links
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US FDA Approved Full Prescribing Information for Hectorol® Capsules
Other Identifiers
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BCI-CH-151
Identifier Type: -
Identifier Source: org_study_id
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