Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
NCT ID: NCT00048451
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
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 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 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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Tucson Therapeutic Research Institute, Inc.
Tucson, Arizona, United States
Pasadena, California, United States
California Institute of Renal Research
San Diego, California, United States
Nephrology Educational Services and Research, Inc.
Tarzana, California, United States
Phoenix Internal Medicine Associates
Waterbury, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Miami Kidney Group
Miami, Florida, United States
ICSL Clinical Studies
Sarasota, Florida, United States
Genesis Clinical Research Corporation
Tampa, Florida, United States
Evanston Northwestern Healthcare
Evanston, Illinois, United States
Medisphere Medical Research Center
Evansville, Indiana, United States
Ochsner Clinic Chronic Dialysis
New Orleans, Louisiana, United States
Biolab Research, LLC
Rockville, Maryland, United States
The Rogosin Institute
New York, New York, United States
Dialysis Clinic, Inc.
Cincinnati, Ohio, United States
Kidney Associates
Houston, Texas, United States
Texas Tech University Health Science Center
Lubbock, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Wojskowy Instytut Medyczny
Warsaw, , Poland
Countries
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Other Identifiers
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2001-020
Identifier Type: -
Identifier Source: org_study_id