Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
1 other identifier
interventional
68
2 countries
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 31, 2002
CompletedFirst Posted
Study publicly available on registry
November 4, 2002
CompletedAugust 2, 2006
July 1, 2006
October 31, 2002
July 31, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- consecutive corrected serum calcium levels between 8.0-10.0 mg/dL
- consecutive serum phosphorus levels of not more than 5.2 mg/mL
You may not qualify if:
- 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 glucocorticoids for a period of more than 14 days within the last 6 months
- HIV positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (19)
Tucson Therapeutic Research Institute, Inc.
Tucson, Arizona, 85712, United States
Unknown Facility
Pasadena, California, 91105, United States
California Institute of Renal Research
San Diego, California, 92120, United States
Nephrology Educational Services and Research, Inc.
Tarzana, California, 91356, United States
Phoenix Internal Medicine Associates
Waterbury, Connecticut, 06708, United States
University of Florida
Gainesville, Florida, 32610, United States
Miami Kidney Group
Miami, Florida, 33143, United States
ICSL Clinical Studies
Sarasota, Florida, 34232, United States
Genesis Clinical Research Corporation
Tampa, Florida, 33614, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
Medisphere Medical Research Center
Evansville, Indiana, 47714, United States
Ochsner Clinic Chronic Dialysis
New Orleans, Louisiana, 70121, United States
Biolab Research, LLC
Rockville, Maryland, 20852, United States
The Rogosin Institute
New York, New York, 10021, United States
Dialysis Clinic, Inc.
Cincinnati, Ohio, 45206, United States
Kidney Associates
Houston, Texas, 77030, United States
Texas Tech University Health Science Center
Lubbock, Texas, 79430, United States
University of Texas Health Science Center
San Antonio, Texas, 78229, United States
Wojskowy Instytut Medyczny
Warsaw, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Laura Williams, M.D.
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 31, 2002
First Posted
November 4, 2002
Study Start
February 1, 2002
Last Updated
August 2, 2006
Record last verified: 2006-07