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| Sponsored by: |
Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00048438 |
Purpose
The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Insufficiency, Chronic |
Drug: paricalcitol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If female:
For entry into Pretreatment Phase:
For entry into Treatment Phase:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCI Medical Center | |
| Orange, California, United States, 92868 | |
| United States, Colorado | |
| Western Nephrology | |
| Thornton, Colorado, United States, 80260 | |
| United States, Florida | |
| Outcomes Research International, Inc. | |
| Hudson, Florida, United States, 34667 | |
| Nephrology Association of South Miami | |
| Miami, Florida, United States, 33173 | |
| Tampa Bay Nephrology Associates | |
| Tampa, Florida, United States, 33603 | |
| United States, Illinois | |
| Northwestern University Medical School | |
| Chicago, Illinois, United States, 60611 | |
| United States, Missouri | |
| Arms, Dodge, Robinson, Wilber and Crouch | |
| Kansas City, Missouri, United States, 64111 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| University of Missouri Health Sciences Center | |
| Columbia, Missouri, United States, 65212 | |
| United States, Nevada | |
| NEA Research | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New York | |
| North Shore University Hospital | |
| Great Neck, New York, United States, 11021 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Wake Nephrology Associates, PA | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| Kidney and Hypertension Center | |
| Cincinnati, Ohio, United States, 45220 | |
| United States, South Carolina | |
| Dorn VA Hospital | |
| Columbia, South Carolina, United States, 29209 | |
| United States, Texas | |
| Dallas Nephrology Associates | |
| Dallas, Texas, United States, 75235 | |
| United States, Washington | |
| The Vancouver Clinic, Inc., P.S. | |
| Vancouver, Washington, United States, 98644 | |
| Poland | |
| Jagiellonian University | |
| Cracow, Poland | |
| Study Director: | Laura Williams, M.D. | Abbott |
More Information
| Study ID Numbers: | 2001-019 |
| Study First Received: | October 31, 2002 |
| Last Updated: | August 10, 2006 |
| ClinicalTrials.gov Identifier: | NCT00048438 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |
|
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |