Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
NCT ID: NCT00048438
Last Updated: 2006-08-15
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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UCI Medical Center
Orange, California, United States
Western Nephrology
Thornton, Colorado, United States
Outcomes Research International, Inc.
Hudson, Florida, United States
Nephrology Association of South Miami
Miami, Florida, United States
Tampa Bay Nephrology Associates
Tampa, Florida, United States
Northwestern University Medical School
Chicago, Illinois, United States
University of Missouri Health Sciences Center
Columbia, Missouri, United States
Arms, Dodge, Robinson, Wilber and Crouch
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
NEA Research
Las Vegas, Nevada, United States
North Shore University Hospital
Great Neck, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Wake Nephrology Associates, PA
Raleigh, North Carolina, United States
Kidney and Hypertension Center
Cincinnati, Ohio, United States
Dorn VA Hospital
Columbia, South Carolina, United States
Dallas Nephrology Associates
Dallas, Texas, United States
The Vancouver Clinic, Inc., P.S.
Vancouver, Washington, United States
Jagiellonian University
Krakow, , Poland
Countries
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Other Identifiers
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2001-019
Identifier Type: -
Identifier Source: org_study_id