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Clinical Trial Details

Trial ID: L0516
Source ID: NCT00123461
Associated Drug: Hectorol (Doxercalciferol Capsules), 0.5mcg
Title: Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Secondary Hyperparathyroidism|Renal Failure|Chronic Renal Insufficiency
Interventions: DRUG: Hectorol (doxercalciferol capsules), 0.5mcg
Outcome Measures: Primary: Laboratory measurement of intact parathyroid hormone (iPTH), 6 months | Secondary: Laboratory measurement of serum bone markers, 6 months
Sponsor/Collaborators: Sponsor: Genzyme, a Sanofi Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 70
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2005-07
Completion Date: 2007-10
Results First Posted:
Last Update Posted: 2015-05-05
Locations: AKDHC Medical Research Services, Phoenix, Arizona, 85012, United States|UCLA Diabetes Reseach Center, Alhambra, California, United States|Apex Research of Riverside, Riverside, California, 92501, United States|George Washington University Hospital, Washington, District of Columbia, 20037, United States|Discovery Medical Research Group, Ocala, Florida, 34471, United States|Nephrology Associates, Palm Beach Gardens, Florida, 33410, United States|Georgia Kidney Associates, Inc., Marietta, Georgia, 30060, United States|Michigan Kidney Consultants, P.C., Pontiac, Michigan, 48341, United States|Twin Cities Clinical Research, Brooklyn Center, Minnesota, 55430, United States|Montefiore Medical Center, Bronx, New York, United States|University of Rochester Medical Center, Rochester, New York, 14642, 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, 58201, United States|DaVita Lewiston Dialysis Center, Lewiston, Pennsylvania, 17044, United States|Temple University, Philadelphia, Pennsylvania, United States|Virginia Commonwealth University, Richmond, Virginia, United States|Instituto Renal del Este, Caguas, 00725, Puerto Rico|Jose Cangiano, MD, San Juan, 00918, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT00123461