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Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly) Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly) Clinical research trials and Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly) healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly). Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly) Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly) clinical trial. Human subjects often receive the most effective healthcare possible for their Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly) condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly)  Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly)
Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly)
For Condition: Renal Insufficiency, Chronic
Status: No longer recruiting
Sponsor(s): Abbott Laboratories ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Under care of physician at least 2 months (for CKD) - Not on active Vitamin D therapy for at least 4 weeks prior - If female: -Not of childbearing potential, OR -Practicing birth control -Not breastfeeding - If taking phosphate binders, on a stable regimen at least 4 weeks prior - For entry into Pretreatment Phase: -iPTH at least 120 pg/mL -GFR of 15-60 mL/min and no dialysis expected for at least 6 months - For entry into Treatment Phase: -Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL -2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL -2 consecutive serum phosphorus levels of not more than 5.2 mg/mL Exclusion Criteria: - History of allergic reaction or sensitivity to similar drugs - Acute Renal Failure within 12 weeks of study - Chronic gastrointestinal disease - Spot urine result demonstrating a urine-calcium-to-urine creatinine ratio of greater than 0.2, or a history of renal stones - Taken aluminum-containing phosphate binders within last 12 weeks, or requires such medication for more than 3 weeks during study - Current malignancy, or clinically significant liver disease - Active granulomatous disease (TB, sarcoidosis, etc.) - History of drug or alcohol abuse within 6 mos. prior - Evidence of poor compliance with diet or medication - Received any investigational drug or participated in any device trial within 30 days prior - Taking maintenance calcitonin, bisphosphonates, or drugs that may affect calcium or bone metabolism (other than females on stable estrogen and/or progestin therapy) - On glucocoricoids for a period of more than 14 days within the last 6 months - HIV positive
Total Enrollment: 68
Location and Contact Information:
Northwestern University Medical School
Chicago, Illinois, 60611
United States
Jagiellonian University
Cracow, ,
Poland
Dallas Nephrology Associates
Dallas, Texas, 75235
United States
NEA Research
Las Vegas, Nevada, 89102
United States
Kidney and Hypertension Center
Cincinnati, Ohio, 45220
United States
North Shore University Hospital
Great Neck, New York, 11021
United States
The Vancouver Clinic, Inc., P.S.
Vancouver, Washington, 98644
United States
Wake Nephrology Associates, PA
Raleigh, North Carolina, 27609
United States
Nephrology Association of South Miami
Miami, Florida, 33173
United States
Dorn VA Hospital
Columbia, South Carolina, 29209
United States
University of Missouri Health Sciences Center
Columbia, Missouri, 65212
United States
Western Nephrology
Thornton, Colorado, 80260
United States
Arms, Dodge, Robinson, Wilber and Crouch
Kansas City, Missouri, 64111
United States
Outcomes Research International, Inc.
Hudson, Florida, 34667
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
UCI Medical Center
Orange, California, 92868
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
Tampa Bay Nephrology Associates
Tampa, Florida, 33603
United States
Additional Information:
Study ID Numbers: 2001-019;
Study Start Date: February 2002
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048438
Other Renal Insufficiency, Chronic Studies:
1. Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly)
2. Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (daily dosing)
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Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly)
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