The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal range. Previous studies with doxercalciferol were conducted in patients who had low levels of vitamin D.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
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
...and 9 more locations
Laboratory measurement of intact parathyroid hormone (iPTH)
Time frame: 6 months
Laboratory measurement of serum bone markers
Time frame: 6 months
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