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Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (daily dosing) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (daily dosing) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (daily dosing) Clinical research trials and Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (daily dosing) health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (daily dosing). Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (daily dosing) Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (daily dosing) clinical trial. Test subjects typically receive the most expert healthcare available for their Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (daily dosing) condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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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 (daily dosing)  Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (daily dosing)
Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (daily dosing)
For Condition: Renal Insufficiency, Chronic
Status: 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 months 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 glucocorticoids for a period of more than 14 days within the last 6 months - HIV positive
Total Enrollment: 68
Location and Contact Information:
FHS Research Center *Recruiting*
Tacoma, Washington, 98405
United States
Recruiting Rebecca Valley 253-426-6384
Denver Nephrologists *Completed*
Denver, Colorado, 80220
United States
Completed
Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Deborah Brooks 843-792-8495
Long Island College Hospital *Recruiting*
Brooklyn, New York, 11201
United States
Recruiting Bien Burgonio 718-780-1415
Nephrology Associates Medical Group *Recruiting*
Riverside, California, 92501
United States
Recruiting Tammy Garrison 909-274-9249
Clinical Research Associates of Tidewater *Completed*
Norfolk, Virginia, 23507
United States
Completed
Avera McKennan Research Institute *Recruiting*
Sioux Falls, South Dakota, 57105
United States
Recruiting Cheryl Ageton 605-322-3064
Krakow Hospital *Recruiting*
Krakow, ,
Poland
Recruiting Olgierd Smolenski
San Antonio Kidney Disease Research Center *Completed*
San Antonio, Texas, 78219
United States
Completed
VA Greater Los Angeles Healthcare System, West Los Angeles *Recruiting*
Los Angeles, California, 90073
United States
Recruiting Karen Knibloe 310-268-4361
Dialysis PC *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Martha Fitzgerald 515-241-5734
University of CO Health Sciences Center *Recruiting*
Denver, Colorado, 80262
United States
Recruiting Andrea Singleton 303-315-6713
Erie County Medical Center *Recruiting*
Buffalo, New York, 14215
United States
Recruiting Suzanne Blas 716-898-4803
Wojewodzki Szpital Specjalistyczny AM w Bialymstoku *Recruiting*
Bialymstoku, ,
Poland
Recruiting Michal Mysliwiec
Twin Cities Clinical Research *Recruiting*
Arden Hills, Minnesota, 55126
United States
Recruiting Serena Larson 651-765-9229
Temple University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19140
United States
Recruiting Carol Chang 215-707-7941
Kidney Center, Inc. *Recruiting*
Simi Valley, California, 93065
United States
Recruiting Claudia Algaze 805-584-0177
Nephrology Associates *Recruiting*
Nashville, Tennessee, 37205
United States
Recruiting Connie Brais 615-354-2406
Additional Information:
Study ID Numbers: 2001-021;
Study Start Date: February 2002
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048516
Other Renal Insufficiency, Chronic Studies:
1. Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (daily dosing)
2. Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three times weekly)
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Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (daily dosing)
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