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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hectorol (doxercalciferol capsules), 0.5mcg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory measurement of intact parathyroid hormone (iPTH) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory measurement of serum bone markers | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKDHC Medical Research Services | Phoenix | Arizona | 85012 | United States | ||
| UCLA Diabetes Reseach Center |
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| Alhambra |
| California |
| United States |
| Apex Research of Riverside | Riverside | California | 92501 | United States |
| George Washington University Hospital | Washington D.C. | 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 |
| University of Rochester Medical Center | Rochester | New York | 14642 | 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 | 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 |
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D051437 | Renal Insufficiency |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C042533 | 1 alpha-hydroxyergocalciferol |
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