Spots Global Cancer Trial Database for Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
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Trial Identification
Brief Title: Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
Official Title: A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in Vitamin D-replete Subjects With Chronic Kidney Disease (CKD) Stages 3 or 4 With Secondary Hyperparathyroidism (SHPT).
Study ID: NCT00123461
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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
Montefiore Medical Center, Bronx, New York, United States
University of Rochester Medical Center, Rochester, 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
Contact Details
Name: Medical Monitor
Affiliation: Genzyme, a Sanofi Company
Role: STUDY_DIRECTOR
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