Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Daily Dosing)
NCT ID: NCT00048516
Last Updated: 2006-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
68 participants
INTERVENTIONAL
2002-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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paricalcitol capsule
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Principal Investigators
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Laura Williams, M.D.
Role: STUDY_DIRECTOR
Abbott
Locations
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VA Greater Los Angeles Healthcare System, West Los Angeles
Los Angeles, California, United States
Nephrology Associates Medical Group
Riverside, California, United States
Kidney Center, Inc.
Simi Valley, California, United States
Denver Nephrologists
Denver, Colorado, United States
University of CO Health Sciences Center
Denver, Colorado, United States
Dialysis PC
Des Moines, Iowa, United States
Twin Cities Clinical Research
Arden Hills, Minnesota, United States
Long Island College Hospital
Brooklyn, New York, United States
Erie County Medical Center
Buffalo, New York, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Avera McKennan Research Institute
Sioux Falls, South Dakota, United States
Nephrology Associates
Nashville, Tennessee, United States
San Antonio Kidney Disease Research Center
San Antonio, Texas, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
FHS Research Center
Tacoma, Washington, United States
Wojewodzki Szpital Specjalistyczny AM w Bialymstoku
Bialymstoku, , Poland
Krakow Hospital
Krakow, , Poland
Countries
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Other Identifiers
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2001-021
Identifier Type: -
Identifier Source: org_study_id