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
18
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
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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 15, 2006
August 1, 2006
October 31, 2002
August 10, 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 (18)
UCI Medical Center
Orange, California, 92868, United States
Western Nephrology
Thornton, Colorado, 80260, United States
Outcomes Research International, Inc.
Hudson, Florida, 34667, United States
Nephrology Association of South Miami
Miami, Florida, 33173, United States
Tampa Bay Nephrology Associates
Tampa, Florida, 33603, United States
Northwestern University Medical School
Chicago, Illinois, 60611, United States
University of Missouri Health Sciences Center
Columbia, Missouri, 65212, United States
Arms, Dodge, Robinson, Wilber and Crouch
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
NEA Research
Las Vegas, Nevada, 89102, United States
North Shore University Hospital
Great Neck, New York, 11021, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Wake Nephrology Associates, PA
Raleigh, North Carolina, 27609, United States
Kidney and Hypertension Center
Cincinnati, Ohio, 45220, United States
Dorn VA Hospital
Columbia, South Carolina, 29209, United States
Dallas Nephrology Associates
Dallas, Texas, 75235, United States
The Vancouver Clinic, Inc., P.S.
Vancouver, Washington, 98644, United States
Jagiellonian University
Krakow, 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 15, 2006
Record last verified: 2006-08