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Sponsored by: |
Genzyme |
---|---|
Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00123461 |
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.
Condition | Intervention | Phase |
---|---|---|
Secondary Hyperparathyroidism Renal Failure Chronic Renal Insufficiency |
Drug: Hectorol (doxercalciferol capsules), 0.5mcg |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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). |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
AKDHC Medical Research Services | |
Phoenix, Arizona, United States, 85012 | |
United States, California | |
UCLA Diabetes Reseach Center | |
Alhambra, California, United States | |
Apex Research of Riverside | |
Riverside, California, United States, 92501 | |
United States, District of Columbia | |
George Washington University Hospital | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Nephrology Associates | |
Palm Beach Gardens, Florida, United States, 33410 | |
Discovery Medical Research Group | |
Ocala, Florida, United States, 34471 | |
United States, Georgia | |
Georgia Kidney Associates, Inc. | |
Marietta, Georgia, United States, 30060 | |
United States, Michigan | |
Michigan Kidney Consultants, P.C. | |
Pontiac, Michigan, United States, 48341 | |
United States, Minnesota | |
Twin Cities Clinical Research | |
Brooklyn Center, Minnesota, United States, 55430 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, North Carolina | |
Wake Forest University School of Medicine | |
Winston-Salem, North Carolina, United States | |
Wake Nephrology Associates, PA | |
Raleigh, North Carolina, United States | |
United States, North Dakota | |
Altru Health System Research Center | |
Grand Forks, North Dakota, United States, 58201 | |
United States, Pennsylvania | |
Temple University | |
Philadelphia, Pennsylvania, United States | |
DaVita Lewiston Dialysis Center | |
Lewiston, Pennsylvania, United States, 17044 | |
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States | |
Puerto Rico | |
Jose Cangiano, MD | |
San Juan, Puerto Rico, 00918 | |
Instituto Renal del Este | |
Caguas, Puerto Rico, 00725 |
Study Director: | Medical Monitor | Genzyme |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | BCI-CH-151 |
Study First Received: | July 21, 2005 |
Last Updated: | July 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00123461 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Parathyroid Diseases Renal Insufficiency Ergocalciferol Ergocalciferols Kidney Failure, Chronic Endocrine System Diseases Bone Density Conservation Agents Trace Elements Hyperparathyroidism, Secondary Vitamin D 1 alpha-hydroxyergocalciferol |
Vitamin D2 Hyperparathyroidism Urologic Diseases Renal Insufficiency, Chronic Vitamins Neoplasm Metastasis Calciferol Micronutrients Kidney Diseases Endocrinopathy Kidney Failure |
Parathyroid Diseases Renal Insufficiency Growth Substances Physiological Effects of Drugs Ergocalciferols Kidney Failure, Chronic Endocrine System Diseases Bone Density Conservation Agents Pharmacologic Actions Hyperparathyroidism, Secondary Neoplastic Processes |
Neoplasms 1 alpha-hydroxyergocalciferol Pathologic Processes Hyperparathyroidism Urologic Diseases Renal Insufficiency, Chronic Vitamins Neoplasm Metastasis Micronutrients Kidney Diseases Kidney Failure |