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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00048451 |
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, Arizona | |
Tucson Therapeutic Research Institute, Inc. | |
Tucson, Arizona, United States, 85712 | |
United States, California | |
Nephrology Educational Services and Research, Inc. | |
Tarzana, California, United States, 91356 | |
California Institute of Renal Research | |
San Diego, California, United States, 92120 | |
Pasadena, California, United States, 91105 | |
United States, Connecticut | |
Phoenix Internal Medicine Associates | |
Waterbury, Connecticut, United States, 06708 | |
United States, Florida | |
ICSL Clinical Studies | |
Sarasota, Florida, United States, 34232 | |
University of Florida | |
Gainesville, Florida, United States, 32610 | |
Miami Kidney Group | |
Miami, Florida, United States, 33143 | |
Genesis Clinical Research Corporation | |
Tampa, Florida, United States, 33614 | |
United States, Illinois | |
Evanston Northwestern Healthcare | |
Evanston, Illinois, United States, 60201 | |
United States, Indiana | |
Medisphere Medical Research Center | |
Evansville, Indiana, United States, 47714 | |
United States, Louisiana | |
Ochsner Clinic Chronic Dialysis | |
New Orleans, Louisiana, United States, 70121 | |
United States, Maryland | |
Biolab Research, LLC | |
Rockville, Maryland, United States, 20852 | |
United States, New York | |
The Rogosin Institute | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Dialysis Clinic, Inc. | |
Cincinnati, Ohio, United States, 45206 | |
United States, Texas | |
Kidney Associates | |
Houston, Texas, United States, 77030 | |
University of Texas Health Science Center | |
San Antonio, Texas, United States, 78229 | |
Texas Tech University Health Science Center | |
Lubbock, Texas, United States, 79430 | |
Poland | |
Wojskowy Instytut Medyczny | |
Warszawa, Poland |
Study Director: | Laura Williams, M.D. | Abbott |
Study ID Numbers: | 2001-020 |
Study First Received: | October 31, 2002 |
Last Updated: | July 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00048451 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 |