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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00048438 |
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) |
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:
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 |
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 |